Matching articles for "lung cancer"
Adagrasib (Krazati) for Colorectal Cancer (online only)
The Medical Letter on Drugs and Therapeutics • August 19, 2024; (Issue 1709)
The RAS GTPase family inhibitor adagrasib (Krazati –
BMS), which received accelerated approval for
treatment of KRAS G12C (glycine-to-cysteine mutation
at codon 12)-mutated locally advanced or...
The RAS GTPase family inhibitor adagrasib (Krazati –
BMS), which received accelerated approval for
treatment of KRAS G12C (glycine-to-cysteine mutation
at codon 12)-mutated locally advanced or metastatic
non-small cell lung cancer (NSCLC) in 2022, has now
received accelerated approval from the FDA for use
with cetuximab for treatment of KRAS G12C-mutated
locally advanced or metastatic colorectal cancer
(CRC) in adults who received prior fluoropyrimidine-,
oxaliplatin-, and irinotecan-based chemotherapy.
Adagrasib is the first KRAS inhibitor to be approved in
the US for treatment of CRC.
Tarlatamab (Imdelltra) for Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • July 8, 2024; (Issue 1706)
Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class
bispecific delta-like ligand 3 (DLL3)-directed CD3
T-cell engager, has received accelerated approval
from the FDA for treatment of...
Tarlatamab-dlle (Imdelltra – Amgen), a first-in-class
bispecific delta-like ligand 3 (DLL3)-directed CD3
T-cell engager, has received accelerated approval
from the FDA for treatment of extensive-stage
small cell lung cancer (SCLC) in adults who had
disease progression on or after platinum-based
chemotherapy. It is the first bispecific DLL3-directed
CD3 T-cell engager to be approved in the US for this
indication. Most patients with SCLC have a response
to initial treatment, but progression generally
occurs within a few months and overall survival is
usually less than 8 months. Accelerated approval of
tarlatamab was based on the overall response rate
and duration of response.
Tepotinib (Tepmetko) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • April 29, 2024; (Issue 1701)
The FDA has granted regular approval to the oral
kinase inhibitor tepotinib (Tepmetko – EMD Serono)
for treatment of adults with metastatic non-small
cell lung cancer (NSCLC) harboring...
The FDA has granted regular approval to the oral
kinase inhibitor tepotinib (Tepmetko – EMD Serono)
for treatment of adults with metastatic non-small
cell lung cancer (NSCLC) harboring mesenchymal-epithelial
transition (MET) exon 14 skipping
alterations. MET exon 14 skipping mutations occur
in 3-4% of NSCLC cases and are associated with
advanced disease and a poor prognosis. Tepotinib
received accelerated approval for the same indication
in 2021 based on initial overall response rates and
duration of response.
Repotrectinib (Augtyro) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • February 19, 2024; (Issue 1696)
The FDA has approved the oral tyrosine kinase
inhibitor repotrectinib (Augtyro – BMS) for treatment
of locally advanced or metastatic ROS1-positive
non-small cell lung cancer (NSCLC) in...
The FDA has approved the oral tyrosine kinase
inhibitor repotrectinib (Augtyro – BMS) for treatment
of locally advanced or metastatic ROS1-positive
non-small cell lung cancer (NSCLC) in adults.
Repotrectinib is the third oral tyrosine kinase inhibitor
to be approved for this indication in the US; crizotinib
(Xalkori) and entrectinib (Rozlytrek) were approved
earlier.
Osimertinib (Tagrisso) for Adjuvant Treatment of NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • August 7, 2023; (Issue 1682)
The FDA has approved osimertinib (Tagrisso –
AstraZeneca), an oral kinase inhibitor, for adjuvant
treatment of non-small cell lung cancer (NSCLC)
after tumor resection in adults who have epidermal
growth...
The FDA has approved osimertinib (Tagrisso –
AstraZeneca), an oral kinase inhibitor, for adjuvant
treatment of non-small cell lung cancer (NSCLC)
after tumor resection in adults who have epidermal
growth factor receptor (EGFR) exon 19 deletions or
exon 21 L858R mutations. Osimertinib is the first
targeted therapy to be approved in the US for this
indication. The drug was previously approved for
first-line treatment of adults with NSCLC with EGFR
exon 19 deletions or exon 21 L858R mutations and for
treatment of EGFR T790M mutation-positive NSCLC
in adults whose disease progressed on or after EGFR
tyrosine kinase inhibitor therapy.
Sotorasib (Lumakras) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • June 12, 2023; (Issue 1678)
Sotorasib (Lumakras — Amgen), an oral KRAS
inhibitor, has received accelerated approval by the
FDA for treatment of KRAS G12C-mutated locally
advanced or metastatic non-small cell lung cancer
(NSCLC) in...
Sotorasib (Lumakras — Amgen), an oral KRAS
inhibitor, has received accelerated approval by the
FDA for treatment of KRAS G12C-mutated locally
advanced or metastatic non-small cell lung cancer
(NSCLC) in adults who received at least one prior
systemic therapy. Accelerated approval was based
on the overall response rate and duration of response.
KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation
is the most common KRAS mutation. Sotorasib is the
first KRAS inhibitor to be approved in the US.
Capmatinib (Tabrecta) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
The FDA has granted regular approval to the oral
kinase inhibitor capmatinib (Tabrecta – Novartis) for
treatment of metastatic non-small cell lung cancer
(NSCLC) in adults whose tumors have a mutation...
The FDA has granted regular approval to the oral
kinase inhibitor capmatinib (Tabrecta – Novartis) for
treatment of metastatic non-small cell lung cancer
(NSCLC) in adults whose tumors have a mutation that
leads to mesenchymal-epithelial transition (MET)
exon 14 skipping. MET exon 14 skipping mutations
occur in 3-4% of NSCLC cases. The drug received
accelerated approval for the same indication in 2020
based on initial overall response rates and duration
of response.
Cemiplimab (Libtayo) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • April 17, 2023; (Issue 1674)
The FDA has approved cemiplimab-rwlc (Libtayo –
Regeneron), an immune checkpoint inhibitor, for use in
combination with platinum-based chemotherapy for
first-line treatment of locally advanced or...
The FDA has approved cemiplimab-rwlc (Libtayo –
Regeneron), an immune checkpoint inhibitor, for use in
combination with platinum-based chemotherapy for
first-line treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) in adults with no
epidermal growth factor receptor (EGFR), anaplastic
lymphoma kinase (ALK), or ROS1 aberrations and
who are not candidates for surgical resection or
chemoradiation. The drug was previously approved
for first-line treatment of NSCLC in patients whose
tumors have high PD-L1 expression and no genomic
tumor aberrations. Cemiplimab is also approved
for treatment of metastatic or locally advanced
squamous cell carcinoma and locally advanced or
metastatic basal cell carcinoma.
Atezolizumab (Tecentriq) for Alveolar Soft Part Sarcoma (online only)
The Medical Letter on Drugs and Therapeutics • April 3, 2023; (Issue 1673)
Atezolizumab (Tecentriq – Genentech), an immune
checkpoint inhibitor, has been approved by the FDA
for treatment of unresectable or metastatic alveolar
soft part sarcoma (ASPS) in patients ≥2 years old....
Atezolizumab (Tecentriq – Genentech), an immune
checkpoint inhibitor, has been approved by the FDA
for treatment of unresectable or metastatic alveolar
soft part sarcoma (ASPS) in patients ≥2 years old. It
was previously approved for treatment of non-small
cell lung cancer, small cell lung cancer, hepatocellular
cancer, and melanoma (see Table 1). Atezolizumab is
the first drug to be approved in the US for treatment
of ASPS. ASPS is a rare disorder that affects mostly
adolescents and young adults; <1% of soft tissue
sarcomas are ASPS.
In Brief: A New Indication for Dabrafenib (Tafinlar) and Trametinib (Mekinist) Combination Therapy (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of...
The oral kinase inhibitors dabrafenib (Tafinlar – GSK)
and trametinib (Mekinist – Novartis) have received
accelerated approval by the FDA for use together
for a fifth indication: treatment of unresectable or
metastatic solid tumors with a BRAF V600E mutation
in patients ≥6 years old who have progressed
following prior treatment and have no satisfactory
alternative treatment options. The combination is not
approved for treatment of colorectal cancer because
of known intrinsic resistance to BRAF inhibition and
dabrafenib is not approved for use in patients with
wild-type BRAF melanoma, anaplastic thyroid cancer
(ATC), or solid tumors.
Tremelimumab (Imjudo) for Metastatic NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • February 6, 2023; (Issue 1669)
The FDA has approved tremelimumab-actl (Imjudo –
AstraZeneca), a cytotoxic T-lymphocyte-associated
antigen 4 (CTLA-4) blocking antibody, for use in
combination with the programmed death-ligand 1
(PD-L1)...
The FDA has approved tremelimumab-actl (Imjudo –
AstraZeneca), a cytotoxic T-lymphocyte-associated
antigen 4 (CTLA-4) blocking antibody, for use in
combination with the programmed death-ligand 1
(PD-L1) blocking antibody durvalumab (Imfinzi)
and platinum-based chemotherapy for treatment of
metastatic non-small cell lung cancer (NSCLC) in
adults with no sensitizing epidermal growth factor
receptor (EGFR) mutations or anaplastic lymphoma
kinase (ALK) genomic tumor aberrations.
Adagrasib (Krazati) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • January 23, 2023; (Issue 1668)
Adagrasib (Krazati – Mirati Therapeutics), a RAS
GTPase family inhibitor, has received accelerated
approval from the FDA for oral treatment of KRAS
G12C-mutated locally advanced or metastatic...
Adagrasib (Krazati – Mirati Therapeutics), a RAS
GTPase family inhibitor, has received accelerated
approval from the FDA for oral treatment of KRAS
G12C-mutated locally advanced or metastatic non-small
cell lung cancer (NSCLC) in adults who received
at least one prior systemic therapy. Accelerated
approval was based on the objective response rate
and duration of response.
Mobocertinib (Exkivity) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 28, 2022; (Issue 1664)
Mobocertinib (Exkivity – Takeda), an oral kinase
inhibitor, has received accelerated approval from the
FDA for treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) with...
Mobocertinib (Exkivity – Takeda), an oral kinase
inhibitor, has received accelerated approval from the
FDA for treatment of locally advanced or metastatic
non-small cell lung cancer (NSCLC) with epidermal
growth factor receptor (EGFR) exon 20 insertion
mutations in adults whose disease has progressed on
or after platinum-based chemotherapy. Accelerated
approval was based on the overall response rate and
duration of response. Mobocertinib is the second
drug to become available in the US for this indication;
the IV EGFR-MET bispecific antibody amivantamab
(Rybrevant) was approved earlier.
Amivantamab (Rybrevant) for Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET
bispecific antibody, has received accelerated
approval from the FDA for IV treatment of locally
advanced or metastatic non-small cell lung...
Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET
bispecific antibody, has received accelerated
approval from the FDA for IV treatment of locally
advanced or metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor receptor
(EGFR) exon 20 insertion mutations in adults whose
disease has progressed on or after platinum-based
chemotherapy. It is the first bispecific antibody
to become available in the US for this indication.
Accelerated approval of the drug was based on the
overall response rate and duration of response.
Lurbinectedin (Zepzelca) for Small-Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • November 14, 2022; (Issue 1663)
The alkylating agent lurbinectedin (Zepzelca – Jazz)
has received accelerated approval from the FDA
for treatment of metastatic small-cell lung cancer
(SCLC) in adults with disease progression on or...
The alkylating agent lurbinectedin (Zepzelca – Jazz)
has received accelerated approval from the FDA
for treatment of metastatic small-cell lung cancer
(SCLC) in adults with disease progression on or after
platinum-based chemotherapy. Accelerated approval
was based on the overall response rate and duration
of response. About 13-15% of lung cancers are small-cell
cancers. Most SCLCs occur in patients who are
current or former smokers.
In Brief: Pembrolizumab (Keytruda) for Cancers with Biomarkers (online only)
The Medical Letter on Drugs and Therapeutics • January 1, 2018; (Issue 1537)
The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have...
The immune checkpoint inhibitor pembrolizumab (Keytruda – Merck), a programmed death receptor-1 (PD-1) inhibitor, has been granted accelerated approval by the FDA for use in adults and children who have unresectable or metastatic microsatellite-instability-high (MSI-H) or mismatch-repair-deficient (dMMR) solid tumors that have progressed following treatment, and do not have any satisfactory alternative treatment options. For metastatic colorectal cancer, the indication is limited to tumors that have progressed following combination treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This is the first approval of a cancer drug based solely on the presence of certain biomarkers, regardless of the organ in which the cancer originated or the histology of the tumor.
MSI-H and dMMR are markers for abnormalities in cancer cells that prevent DNA replication and postreplicative DNA repair.1 These biomarkers are found most commonly in cancers of the endometrium, stomach, and colon. The incidence of MSI-H or dMMR in these tumors appears to be lower in advanced disease than in early-stage disease; about 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.2
FDA approval was based on data from five unpublished, single-arm trials of pembrolizumab (summarized in the package insert) that included a total of 149 previously treated adults with various MSI-H or dMMR metastatic or unresectable tumors (90 patients had colorectal cancer). The overall objective response rate was 39.6% and the complete response rate was 7.4%. The median duration of response had not been reached by the end of the study; 78.0% of patients had a response duration of ≥6 months. Adverse reactions, including immune-mediated effects, were similar to those reported previously with pembrolizumab.
The recommended adult dosage of pembrolizumab for this indication is 200 mg IV (2 mg/kg up to a maximum of 200 mg for children) every 3 weeks for a maximum of 24 months. The cost for one adult dose is about $9162.3
Pembrolizumab was previously approved for treatment of unresectable or metastatic melanoma,4 metastatic non-small cell lung cancer (NSCLC), including nonsquamous NSCLC in combination with pemetrexed and carboplatin,5 recurrent or metastatic head and neck squamous cell carcinoma, refractory classical Hodgkin lymphoma, locally advanced or metastatic urothelial carcinoma,6 and recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
Download complete U.S. English article
MSI-H and dMMR are markers for abnormalities in cancer cells that prevent DNA replication and postreplicative DNA repair.1 These biomarkers are found most commonly in cancers of the endometrium, stomach, and colon. The incidence of MSI-H or dMMR in these tumors appears to be lower in advanced disease than in early-stage disease; about 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors.2
FDA approval was based on data from five unpublished, single-arm trials of pembrolizumab (summarized in the package insert) that included a total of 149 previously treated adults with various MSI-H or dMMR metastatic or unresectable tumors (90 patients had colorectal cancer). The overall objective response rate was 39.6% and the complete response rate was 7.4%. The median duration of response had not been reached by the end of the study; 78.0% of patients had a response duration of ≥6 months. Adverse reactions, including immune-mediated effects, were similar to those reported previously with pembrolizumab.
The recommended adult dosage of pembrolizumab for this indication is 200 mg IV (2 mg/kg up to a maximum of 200 mg for children) every 3 weeks for a maximum of 24 months. The cost for one adult dose is about $9162.3
Pembrolizumab was previously approved for treatment of unresectable or metastatic melanoma,4 metastatic non-small cell lung cancer (NSCLC), including nonsquamous NSCLC in combination with pemetrexed and carboplatin,5 recurrent or metastatic head and neck squamous cell carcinoma, refractory classical Hodgkin lymphoma, locally advanced or metastatic urothelial carcinoma,6 and recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
- A Copija et al. Clinical significance and prognostic relevance of microsatellite instability in sporadic colorectal cancer patients. Int J Mol Sci 2017 Jan 6 (epub).
- S Lemery et al. First FDA approval agnostic of cancer site - when a biomarker defines the indication. N Engl J Med 2017; 377:1409.
- Approximate WAC. WAC represents a published catalogue or list price and may not represent an actual transactional price. Source: AnalySource® Monthly. December 5, 2017. Reprinted with permission by First Databank, Inc. All rights reserved. ©2017. www. fdbhealth.com/policies/drug-pricing-policy.
- Pembrolizumab (Keytruda) for metastatic melanoma. Med Lett Drugs Ther 2014; 56: e114.
- Pembrolizumab (Keytruda) for first-line treatment of metastatic NSCLC. Med Lett Drugs Ther 2017; 59:22.
- Three more immune checkpoint inhibitors for advanced bladder cancer. Med Lett Drugs Ther 2017; 59:e202.
Download complete U.S. English article
Atezolizumab (Tecentriq) for Bladder Cancer and NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • February 27, 2017; (Issue 1515)
The FDA has approved the immune checkpoint
inhibitor atezolizumab (Tecentriq – Genentech) for
treatment of locally advanced or metastatic urothelial
carcinoma and metastatic non-small cell lung...
The FDA has approved the immune checkpoint
inhibitor atezolizumab (Tecentriq – Genentech) for
treatment of locally advanced or metastatic urothelial
carcinoma and metastatic non-small cell lung cancer
(NSCLC) that have progressed during or following
platinum-based chemotherapy. Atezolizumab is the
first programmed death-ligand 1 (PD-L1) blocking
antibody to become available in the US. Two other
immune checkpoint inhibitors, the programmed death
receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and
pembrolizumab (Keytruda), are also approved for
treatment of metastatic NSCLC, and nivolumab is
also approved for second-line treatment of locally
advanced or metastatic urothelial carcinoma.
Pembrolizumab (Keytruda) for First-Line Treatment of Metastatic NSCLC
The Medical Letter on Drugs and Therapeutics • January 30, 2017; (Issue 1513)
The FDA has approved the immune checkpoint inhibitor
pembrolizumab (Keytruda – Merck), a programmed
death receptor-1 (PD-1) inhibitor, for first-line treatment
of patients with metastatic non-small cell...
The FDA has approved the immune checkpoint inhibitor
pembrolizumab (Keytruda – Merck), a programmed
death receptor-1 (PD-1) inhibitor, for first-line treatment
of patients with metastatic non-small cell lung cancer
(NSCLC) that highly expresses programmed death-ligand
1 (PD-L1) and has no epidermal growth factor
receptor (EGFR) mutations or anaplastic lymphoma
kinase (ALK) translocations. About 25% of patients with
advanced NSCLC have tumors with high levels of PD-L1
expression (PD-L1 expressed on ≥50% of tumor cells).
Pembrolizumab was approved earlier for treatment of
metastatic NSCLC with PD-L1 expression ≥1% that
progressed on or after platinum-based chemotherapy.
Addendum: Nivolumab (Opdivo) for Metastatic Melanoma and Metastatic NSCLC
The Medical Letter on Drugs and Therapeutics • June 22, 2015; (Issue 1471)
After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June...
After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available supporting the efficacy of the drug in previously untreated melanoma and previously treated nonsquamous NSCLC.
MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free survival, a primary endpoint, improved by 43% with nivolumab (median 6.9 months) and by 58% with combination therapy (median 11.5 months), compared to ipilimumab (median 2.9 months). In patients with tumors that expressed the programmed death ligand 1 (PD-L1) on ≥5% of cells, median progression-free survival was similar in the nivolumab and combination groups (both 14.0 months); in those with tumors that expressed PD-L1 on <5% of cells, it was 5.3 months with nivolumab alone and 11.2 months with both drugs. Rates of complete or partial response were 19.0% with ipilimumab, 43.7% with nivolumab, and 57.6% with combination therapy. At least one severe (grade 3-4) drug-related adverse effect occurred in 27.3% of patients receiving ipilimumab, 16.3% of those receiving nivolumab, and 55.0% of those receiving both drugs.2
NONSQUAMOUS NSCLC – In an open-label trial (available only as an abstract), 582 patients with advanced nonsquamous NSCLC that had progressed during or after treatment with a platinum doublet-based regimen (and, if appropriate, a kinase inhibitor) were randomized to receive nivolumab or docetaxel until disease progression or unacceptable toxicity occurred. Nivolumab significantly improved overall survival, the primary endpoint, by 27% compared to docetaxel (median 12.2 vs 9.4 months). Survival rates in the two groups were similar in patients with tumors expressing PD-L1 on <1% of cells, but in patients with tumors expressing PD-L1 on ≥1%, ≥5%, and ≥10% of cells, nivolumab improved overall survival by 41%, 57%, and 60%, respectively, compared to docetaxel. Patients receiving nivolumab were significantly more likely to have an objective response (19.2% vs 12.4%). Severe (grade 3+) drug-related adverse effects occurred in 10.5% of patients receiving nivolumab and in 53.7% of those receiving docetaxel.3
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MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free survival, a primary endpoint, improved by 43% with nivolumab (median 6.9 months) and by 58% with combination therapy (median 11.5 months), compared to ipilimumab (median 2.9 months). In patients with tumors that expressed the programmed death ligand 1 (PD-L1) on ≥5% of cells, median progression-free survival was similar in the nivolumab and combination groups (both 14.0 months); in those with tumors that expressed PD-L1 on <5% of cells, it was 5.3 months with nivolumab alone and 11.2 months with both drugs. Rates of complete or partial response were 19.0% with ipilimumab, 43.7% with nivolumab, and 57.6% with combination therapy. At least one severe (grade 3-4) drug-related adverse effect occurred in 27.3% of patients receiving ipilimumab, 16.3% of those receiving nivolumab, and 55.0% of those receiving both drugs.2
NONSQUAMOUS NSCLC – In an open-label trial (available only as an abstract), 582 patients with advanced nonsquamous NSCLC that had progressed during or after treatment with a platinum doublet-based regimen (and, if appropriate, a kinase inhibitor) were randomized to receive nivolumab or docetaxel until disease progression or unacceptable toxicity occurred. Nivolumab significantly improved overall survival, the primary endpoint, by 27% compared to docetaxel (median 12.2 vs 9.4 months). Survival rates in the two groups were similar in patients with tumors expressing PD-L1 on <1% of cells, but in patients with tumors expressing PD-L1 on ≥1%, ≥5%, and ≥10% of cells, nivolumab improved overall survival by 41%, 57%, and 60%, respectively, compared to docetaxel. Patients receiving nivolumab were significantly more likely to have an objective response (19.2% vs 12.4%). Severe (grade 3+) drug-related adverse effects occurred in 10.5% of patients receiving nivolumab and in 53.7% of those receiving docetaxel.3
- Nivolumab (Opdivo) for metastatic melanoma and metastatic NSCLC. Med Lett Drugs Ther 2015; 57:85.
- J Larkin et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015 May 31 (epub).
- L Paz-Ares et al. Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC). J Clin Oncol 2015; 33 (suppl; abstr LBA109). Available at: abstracts.asco.org. Accessed June 11, 2015.
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Nivolumab (Opdivo) for Metastatic Melanoma and Metastatic NSCLC
The Medical Letter on Drugs and Therapeutics • June 8, 2015; (Issue 1470)
The FDA has approved nivolumab (Opdivo – BMS),
an IV programmed death receptor-1 (PD-1) blocking
antibody, for treatment of unresectable or metastatic
melanoma that has progressed following treatment
with...
The FDA has approved nivolumab (Opdivo – BMS),
an IV programmed death receptor-1 (PD-1) blocking
antibody, for treatment of unresectable or metastatic
melanoma that has progressed following treatment
with ipilimumab (and a BRAF inhibitor in patients who
are BRAF V600 mutation positive) and for treatment
of metastatic squamous non-small cell lung cancer
(NSCLC) that has progressed on or after platinum-based
chemotherapy. It is the second PD-1 inhibitor to
be marketed in the US after pembrolizumab (Keytruda),
and the first to be approved for treatment of NSCLC.
Afatinib (Gilotrif) for Advanced Non-Small Cell Lung Cancer (online only)
The Medical Letter on Drugs and Therapeutics • May 25, 2015; (Issue 1469)
The FDA has approved afatinib (Gilotrif — Boehringer
Ingelheim), an oral epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitor, for first-line treatment
of patients with metastatic non-small...
The FDA has approved afatinib (Gilotrif — Boehringer
Ingelheim), an oral epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitor, for first-line treatment
of patients with metastatic non-small cell lung cancer
(NSCLC) whose tumors have EGFR exon 19 deletions
or exon 21 (L858R) substitution mutations. These
mutations occur in about 10% of patients with NSCLC.
Afatinib is the second EGFR inhibitor to be approved
for first-line treatment of advanced lung cancer. The
first was erlotinib (Tarceva), which is also approved
for treatment of patients with locally advanced or
metastatic lung cancer that has not responded to at
least one treatment with chemotherapy.
Ramucirumab (Cyramza) for Gastric and GEJ Cancer (online only)
The Medical Letter on Drugs and Therapeutics • May 11, 2015; (Issue 1468)
Ramucirumab (Cyramza – Lilly), a monoclonal antibody
that inhibits vascular endothelial growth factor
receptor 2 (VEGFR2), has been approved by the FDA for
use as monotherapy or in combination with...
Ramucirumab (Cyramza – Lilly), a monoclonal antibody
that inhibits vascular endothelial growth factor
receptor 2 (VEGFR2), has been approved by the FDA for
use as monotherapy or in combination with paclitaxel
for treatment of advanced or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma
that has progressed on or after platinum- or
fluoropyrimidine-based chemotherapy. Ramucirumab
is also approved for use in combination with docetaxel
(Taxotere, and others) for treatment of metastatic
non-small cell lung cancer that has progressed on or
after platinum-based chemotherapy.
Ceritinib (Zykadia) for Non-Small Cell Lung Cancer
The Medical Letter on Drugs and Therapeutics • July 21, 2014; (Issue 1447)
Ceritinib (Zykadia – Novartis), an oral tyrosine
kinase inhibitor, has received accelerated approval
from the FDA for treatment of patients with anaplastic
lymphoma kinase (ALK)-positive...
Ceritinib (Zykadia – Novartis), an oral tyrosine
kinase inhibitor, has received accelerated approval
from the FDA for treatment of patients with anaplastic
lymphoma kinase (ALK)-positive metastatic
non-small cell lung cancer (NSCLC) who have
progressed on or are intolerant to crizotinib (Xalkori).
It is the second tyrosine kinase inhibitor to be approved
for ALK-positive metastatic NSCLC; crizotinib was the
first. Translocations of the ALK gene are found in
about 5% of lung cancers; they occur predominantly
in nonsmokers with adenocarcinoma.
Nutritional Supplements for Age-Related Macular Degeneration Revisited
The Medical Letter on Drugs and Therapeutics • June 24, 2013; (Issue 1419)
The results of the Age-Related Eye Disease Study 2
(AREDS2) have now been published. The primary purpose
of the study was to evaluate the efficacy and safety
of the carotenoids lutein and zeaxanthin and...
The results of the Age-Related Eye Disease Study 2
(AREDS2) have now been published. The primary purpose
of the study was to evaluate the efficacy and safety
of the carotenoids lutein and zeaxanthin and the
omega-3 polyunsaturated fatty acids (PUFAs) docosahexaenoic
acid (DHA) and eicosapentaenoic acid (EPA)
in reducing the risk of developing advanced age-related
macular degeneration (AMD). A secondary goal was to
test the effects of reducing the amount of zinc and eliminating
beta carotene from the original AREDS formulation.
Beta carotene has been shown to increase the
risk of lung cancer in smokers and former smokers.
Cancer Screening
The Medical Letter on Drugs and Therapeutics • December 1, 2012; (Issue 124)
Use of screening tests to identify cancers before they cause symptoms can lead to earlier therapy and may
improve outcomes. Screening tests for some common
cancers are reviewed...
Use of screening tests to identify cancers before they cause symptoms can lead to earlier therapy and may
improve outcomes. Screening tests for some common
cancers are reviewed below.
Crizotinib (Xalkori) for Non-Small Cell Lung Cancer
The Medical Letter on Drugs and Therapeutics • February 6, 2012; (Issue 1383)
The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the anaplastic lymphoma kinase...
The FDA has approved crizotinib (Xalkori – Pfizer), an oral tyrosine kinase inhibitor, for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the anaplastic lymphoma kinase (ALK) translocation, which is found in about 4-5% of lung cancers. A diagnostic test (Vysis ALK Break Apart FISH Probe Kit – Abbott Molecular) is available to detect translocations of the ALK gene in tumor samples; these translocations occur predominantly in nonsmokers with adenocarcinoma.
Vitamins for Cataract Prevention
The Medical Letter on Drugs and Therapeutics • June 16, 2008; (Issue 1288)
Cataracts are the leading cause of blindness worldwide because cataract surgery is not available to most people in developing...
Cataracts are the leading cause of blindness worldwide because cataract surgery is not available to most people in developing countries.
Invader UGT1A1 Molecular Assay for Irinotecan Toxicity
The Medical Letter on Drugs and Therapeutics • May 8, 2006; (Issue 1234)
The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular...
The FDA has approved a new genetic test to identify patients who may be at increased risk of severe toxicity when treated with the cancer chemotherapy drug irinotecan (Camptosar). The Invader UGT1A1 Molecular Assay (Third Wave Technologies) detects the UGT1A1*28 allele, a variation in the uridine diphosphate glucuronosyltranferase 1A1 (UGT1A1) gene. The FDA recently revised the safety labeling for irinotecan, recommending that the dosing of irinotecan be reduced for patients who are homozygous for the UGT1A1*28 allele.
Erlotinib (Tarceva) for Advanced Non-Small Cell Lung Cancer
The Medical Letter on Drugs and Therapeutics • March 28, 2005; (Issue 1205)
Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a...
Erlotinib (Tarceva) is the second oral epidermal growth factor receptor (EGFR) inhibitor to become available in the US for treatment of advanced refractory NSCLC. In clinical trials, erlotinib produced a response rate of only 8.9%, but increased median survival from 4.7 to 6.7 months. Patients who had never smoked and those with EGFR-positive tumors survived longer. Erlotinib is generally well tolerated; diarrhea and rash are the most common adverse effects.
Two New Drugs for Colon Cancer
The Medical Letter on Drugs and Therapeutics • June 7, 2004; (Issue 1184)
Cetuximab (Erbitux - ImClone Systems/Bristol-Myers Squibb), an epidermal growth factor receptor (EGFR) inhibitor, and bevacizumab (Avastin - Genentech), the first vascular endothelial growth factor angiogenesis...
Cetuximab (Erbitux - ImClone Systems/Bristol-Myers Squibb), an epidermal growth factor receptor (EGFR) inhibitor, and bevacizumab (Avastin - Genentech), the first vascular endothelial growth factor angiogenesis inhibitor, have recently been approved by the FDA for treatment of patients with metastatic colorectal cancer. Cetuximab is approved for treatment of patients with EGFR-expressing tumors, either in combination regimens with irinotecan (Camptosar)when the cancer has progressed on irinotecan-based therapy, or as monotherapy for those who cannot tolerate irinotecan. Bevacizumab is approved for first-line therapy in combination with a fluorouracil-based regimen.
Drugs of Choice for Cancer
The Medical Letter on Drugs and Therapeutics • March 1, 2003; (Issue 7)
The tables in this article list drugs used for treatment of cancer in the USA and Canada and their major adverse effects. The choice of drugs in Table I is based on the opinions of Medical Letter consultants....
The tables in this article list drugs used for treatment of cancer in the USA and Canada and their major adverse effects. The choice of drugs in Table I is based on the opinions of Medical Letter consultants. Some drugs are listed for indications for which they have not been approved by the US Food and Drug Administration. In some cases, such as elderly patients or those with many co-morbid illnesses, the regimen of choice might not be suitable. For many of the cancers listed, surgery and/or radiation therapy may be the treatment of choice or may also be part of the management. Anticancer drugs and their adverse effects are listed in Table II on page 46. A partial list of brand names appears on page 52.
Gefitinib (Iressa) for advanced non-small cell lung cancer
The Medical Letter on Drugs and Therapeutics • September 2, 2002; (Issue 1138)
Patients with lung cancer may be asking their physicians about gefitinib (ge fi' tye nib; ZD1839; Iressa -- AstraZeneca), because it has been the subject of positive coverage in the media. An inhibitor of the...
Patients with lung cancer may be asking their physicians about gefitinib (ge fi' tye nib; ZD1839; Iressa -- AstraZeneca), because it has been the subject of positive coverage in the media. An inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, this oral drug has not been approved by the FDA, but is in clinical trials in the US for treatment of non-small cell lung cancer (NSCLC) and some other solid tumors. Iressa was recently approved in Japan, and is available from the manufacturer on a "compassionate-use" basis in the US (800-236-9933).
Vinorelbine For Treatment of Advanced Non-Small-Cell Lung Cancer
The Medical Letter on Drugs and Therapeutics • August 18, 1995; (Issue 955)
Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung...
Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung cancer (NSCLC). Various combinations of cisplatin (Platinol), vinblastine (Velban, and others), mitomycin (Mutamycin), ifosfamide (Ifex), etoposide (VePesid) and paclitaxel (Taxol) have been used previously for this indication.