A nephrologist and longtime reader of The Medical Letter wrote us to say that our recent article entitled Drugs for Anxiety Disorders should have said more about the need for dosage adjustment of gabapentin (Neurontin, and others) and pregabalin (Lyrica, and others) in patients with renal impairment. Both drugs, he pointed out, are exclusively renally eliminated and can accumulate in patients with diminished renal function. Symptoms, which can include altered mental status, may develop so slowly that neither the patient nor the practitioner connect them to the drug. The resolution of...

Epsolay (Galderma), a 5% benzoyl peroxide cream, has been approved by the FDA for treatment of inflammatory lesions of rosacea in adults. It is the first product containing benzoyl peroxide to be approved in the US for treatment of rosacea. Benzoyl peroxide formulations approved for acne have been used off-label to treat rosacea for years, but itching and burning have limited their use.

The FDA has approved vutrisiran (Amvuttra – Alnylam), a subcutaneously injected small interfering RNA (siRNA), to reduce cardiovascular hospitalizations, urgent heart failure visits, and cardiovascular death in adults with wild-type or variant transthyretin amyloid cardiomyopathy (ATTR-CM). Vutrisiran is the first siRNA to be approved in the US for this indication; it was approved earlier for treatment of polyneuropathy associated with hereditary transthyretin-mediated amyloidosis.

View the Comparison Table: Some Oral/Transdermal Opioid Analgesics

Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional randomized controlled trial to establish that reducing amyloid beta plaques with aducanumab improves clinical outcomes in patients with Alzheimer's disease.

Difelikefalin (Korsuva – Vifor), an IV kappa opioid receptor (KOR) agonist, has been approved by the FDA for treatment of moderate to severe pruritus associated with chronic kidney disease (CKD) in adults on hemodialysis. It is the first drug to be approved for this indication and the first KOR agonist to become available in the US. Difelikefalin has not been studied in patients on peritoneal dialysis.

Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for first-line treatment of diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) in adults who have an International Prognostic Index (IPI) score ≥2. The drug was previously approved for use in combination with bendamustine and rituximab for treatment of patients with relapsed or refactory DLBCL,...

Asciminib (Scemblix – Novartis), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with ≥2 tyrosine kinase inhibitors and for adults with Ph+ CML in CP with a T315I mutation.

The oral gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix (Orgovyx – Myovant Sciences/Pfizer) has been approved by the FDA for treatment of advanced prostate cancer in adults. It is the first oral GnRH receptor antagonist to become available in the US; degarelix (Firmagon), an injectable GnRH receptor antagonist, has been available since 2008 for the same indication.

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.