Matching articles for "melanoma"

Lifileucel (Amtagvi): A Cellular Therapy for Melanoma (online only)

   
The Medical Letter on Drugs and Therapeutics • April 29, 2024;  (Issue 1701)
Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma...
Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.
Med Lett Drugs Ther. 2024 Apr 29;66(1701):e77-8 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2023 Apr 3;65(1673):e56-7 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2023 Feb 6;65(1669):e26-7 | Show Full IntroductionHide Full Introduction

Opdualag for Metastatic Melanoma (online only)

   
The Medical Letter on Drugs and Therapeutics • January 23, 2023;  (Issue 1668)
Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation...
Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors nivolumab and pembrolizumab (Keytruda), have been available for several years for treatment of melanoma.
Med Lett Drugs Ther. 2023 Jan 23;65(1668):e19-20 | Show Full IntroductionHide Full Introduction

Sunscreens

   
The Medical Letter on Drugs and Therapeutics • July 26, 2021;  (Issue 1629)
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and...
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.
Med Lett Drugs Ther. 2021 Jul 26;63(1629):115-20 | Show Full IntroductionHide Full Introduction

In Brief: Hydrochlorothiazide and Skin Cancer

   
The Medical Letter on Drugs and Therapeutics • November 16, 2020;  (Issue 1611)
The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the...
The FDA has required the addition of information about an increased risk of nonmelanoma skin cancer (basal cell carcinoma [BCC] and squamous cell carcinoma [SCC]) to the labels of products containing the diuretic hydrochlorothiazide.
Med Lett Drugs Ther. 2020 Nov 16;62(1611):177 | Show Full IntroductionHide Full Introduction

Sunscreens

   
The Medical Letter on Drugs and Therapeutics • August 13, 2018;  (Issue 1553)
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but some questions remain about...
Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but some questions remain about their effectiveness and safety.
Med Lett Drugs Ther. 2018 Aug 13;60(1553):129-32 | Show Full IntroductionHide Full Introduction

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.

  1. 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).
  2. S Lemery et al. First FDA approval agnostic of cancer site - when a biomarker defines the indication. N Engl J Med 2017; 377:1409.
  3. 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.
  4. Pembrolizumab (Keytruda) for metastatic melanoma. Med Lett Drugs Ther 2014; 56: e114.
  5. Pembrolizumab (Keytruda) for first-line treatment of metastatic NSCLC. Med Lett Drugs Ther 2017; 59:22.
  6. Three more immune checkpoint inhibitors for advanced bladder cancer. Med Lett Drugs Ther 2017; 59:e202.


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Med Lett Drugs Ther. 2018 Jan 1;60(1537):e8 | Show Full IntroductionHide Full Introduction

Cobimetinib (Cotellic) for Metastatic Melanoma

   
The Medical Letter on Drugs and Therapeutics • March 28, 2016;  (Issue 1491)
The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor...
The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.
Med Lett Drugs Ther. 2016 Mar 28;58(1491):43-4 | Show Full IntroductionHide Full Introduction

Talimogene Laherparepvec (Imlygic) for Unresectable Melanoma

   
The Medical Letter on Drugs and Therapeutics • January 18, 2016;  (Issue 1486)
The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in...
The FDA has approved talimogene laherparepvec (Imlygic – Amgen), a genetically modified herpes simplex virus, for intralesional treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma that has recurred following surgery. It is the first oncolytic virotherapy to become available in the US.
Med Lett Drugs Ther. 2016 Jan 18;58(1486):8-9 | Show Full IntroductionHide Full Introduction

Nivolumab (Opdivo) plus Ipilimumab (Yervoy) for Metastatic Melanoma

   
The Medical Letter on Drugs and Therapeutics • December 7, 2015;  (Issue 1483)
The FDA has approved the combined use of the programmed death receptor-1 (PD-1) blocking antibody nivolumab (Opdivo) and the anti-CLA-4 antibody ipilimumab (Yervoy) for treatment of BRAF V600 wild-type...
The FDA has approved the combined use of the programmed death receptor-1 (PD-1) blocking antibody nivolumab (Opdivo) and the anti-CLA-4 antibody ipilimumab (Yervoy) for treatment of BRAF V600 wild-type unresectable or metastatic melanoma. This is the first immunotherapy combination to be approved for treatment of any type of cancer.
Med Lett Drugs Ther. 2015 Dec 7;57(1483):168 | Show Full IntroductionHide Full Introduction

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

  1. Nivolumab (Opdivo) for metastatic melanoma and metastatic NSCLC. Med Lett Drugs Ther 2015; 57:85.
  2. J Larkin et al. Combined nivolumab and ipilimumab or monotherapy in untreated melanoma. N Engl J Med 2015 May 31 (epub).
  3. 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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Med Lett Drugs Ther. 2015 Jun 22;57(1471):94 | Show Full IntroductionHide Full Introduction

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.
Med Lett Drugs Ther. 2015 Jun 8;57(1470):85-7 | Show Full IntroductionHide Full Introduction

Pembrolizumab (Keytruda) for Metastatic Melanoma (online only)

   
The Medical Letter on Drugs and Therapeutics • November 10, 2014;  (Issue 1455)
The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed...
The FDA has approved pembrolizumab (Keytruda – Merck), a human programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (Yervoy) and, if the patient is BRAF V600 mutation positive, a BRAF inhibitor. It is the fi rst PD-1 inhibitor to be marketed in the US. Nivolumab, another PD-1 inhibitor, is available in Japan. Pembrolizumab was previously known as lambrolizumab.
Med Lett Drugs Ther. 2014 Nov 10;56(1455):e114-5 | Show Full IntroductionHide Full Introduction

Dabrafenib (Tafinlar) and Trametinib (Mekinist) for Metastatic Melanoma

   
The Medical Letter on Drugs and Therapeutics • August 5, 2013;  (Issue 1422)
The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist –...
The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist – GSK) for melanomas with either BRAF V600E or V600K mutations. Dabrafenib is not recommended for patients with wild-type BRAF (BRAF-negative) melanoma, and trametinib is not recommended for patients who have received prior BRAF-inhibitor therapy.
Med Lett Drugs Ther. 2013 Aug 5;55(1422):62-3 | Show Full IntroductionHide Full Introduction

Vemurafenib (Zelboraf) for Metastatic Melanoma

   
The Medical Letter on Drugs and Therapeutics • October 3, 2011;  (Issue 1374)
The FDA has approved vemurafenib (Zelboraf – Genentech), a kinase inhibitor, for treatment of unresectable or metastatic melanoma with the BRAF V600E mutation, which is found in 30-60% of melanomas. An...
The FDA has approved vemurafenib (Zelboraf – Genentech), a kinase inhibitor, for treatment of unresectable or metastatic melanoma with the BRAF V600E mutation, which is found in 30-60% of melanomas. An FDA-approved test can detect the mutation in DNA from melanoma tissue.
Med Lett Drugs Ther. 2011 Oct 3;53(1374):77-8 | Show Full IntroductionHide Full Introduction

Peginterferon Alfa-2b (Sylatron) for Melanoma

   
The Medical Letter on Drugs and Therapeutics • September 19, 2011;  (Issue 1373)
The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon...
The FDA has approved peginterferon alfa-2b (Sylatron – Merck) for adjuvant treatment of node-positive melanoma after surgical resection. Pegylated interferon has a longer duration of action than interferon alfa-2b (Intron A), which is also FDA-approved for adjuvant treatment of malignant melanoma after surgery, and can be given once a week, compared to 3-5 times a week for standard interferon.
Med Lett Drugs Ther. 2011 Sep 19;53(1373):76 | Show Full IntroductionHide Full Introduction

Screening for Melanoma

   
The Medical Letter on Drugs and Therapeutics • September 5, 2011;  (Issue 1372)
In the absence of randomized studies demonstrating an impact on mortality, the US Preventive Services Task Force (USPSTF) has found the evidence insufficient to recommend a routine whole-body...
In the absence of randomized studies demonstrating an impact on mortality, the US Preventive Services Task Force (USPSTF) has found the evidence insufficient to recommend a routine whole-body examination for melanoma and other skin cancers.
Med Lett Drugs Ther. 2011 Sep 5;53(1372):72 | Show Full IntroductionHide Full Introduction

Ipilimumab (Yervoy) for Metastatic Melanoma

   
The Medical Letter on Drugs and Therapeutics • June 27, 2011;  (Issue 1367)
The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic...
The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic melanoma.
Med Lett Drugs Ther. 2011 Jun 27;53(1367):51-2 | Show Full IntroductionHide Full Introduction

Sunscreens Revisited

   
The Medical Letter on Drugs and Therapeutics • March 7, 2011;  (Issue 1359)
...
Sunscreens are widely used now, but some questions remain about their effectiveness and safety.
Med Lett Drugs Ther. 2011 Mar 7;53(1359):17-8 | Show Full IntroductionHide Full Introduction

A New Sunscreen Agent

   
The Medical Letter on Drugs and Therapeutics • May 20, 2007;  (Issue 1261)
Ecamsule (terephthalylidene dicamphor sulfonic acid), the first new sunscreen agent to be approved by the FDA in 18 years, is now available in the US in a moisturizer called Anthelios SX. Ecamsule has been used...
Ecamsule (terephthalylidene dicamphor sulfonic acid), the first new sunscreen agent to be approved by the FDA in 18 years, is now available in the US in a moisturizer called Anthelios SX. Ecamsule has been used in Canada and Europe for more than 10 years.
Med Lett Drugs Ther. 2007 May 20;49(1261):41-3 | Show Full IntroductionHide Full Introduction

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.
Treat Guidel Med Lett. 2003 Mar;1(7):41-52 | Show Full IntroductionHide Full Introduction

Drugs of Choice For Cancer Chemotherapy (combined issue 1087-1088)

   
The Medical Letter on Drugs and Therapeutics • September 18, 2000;  (Issue 1087)
The tables in this article list drugs used for treatment of cancer in the USA and Canada. The choices of drugs in Table 1 is based on the opinions of Medical Letter consultants. Some drugs are listed for...
The tables in this article list drugs used for treatment of cancer in the USA and Canada. The choices of drugs in Table 1 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. For many of the cancers listed, surgery and/or radiation therapy are also part of the management of the disease.
Med Lett Drugs Ther. 2000 Sep 18;42(1087):83-92 | Show Full IntroductionHide Full Introduction