The FDA has approved tebentafusp-tebn (Kimmtrak – Immunocore), a first-in-class bispecific gp100 peptide-HLA-directed CD3 T-cell engager, for treatment of HLA-A*02:01-positive unresectable or metastatic uveal melanoma in adults.

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....

The FDA has approved a 0.15% cream formulation of the phosphodiesterase-4 (PDE4) inhibitor roflumilast (Zoryve – Arcutis) for topical treatment of mild to moderate atopic dermatitis (AD) in patients ≥6 years old. Roflumilast is the second PDE4 inhibitor to be approved in the US for treatment of AD; crisaborole (Eucrisa), which can be used in patients ≥3 months old, was the first. Roflumilast is available as Zoryve in a 0.3% cream for treatment of plaque psoriasis and a 0.3% foam for treatment of seborrheic dermatitis. It is also available in an oral formulation (Daliresp) for...

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...

Many prescriptions for eye drops call for instillation of 1-2 drops. But Medical Letter consultants in ophthalmology seem to agree that all eye drops should generally be given in doses of only one drop. The volume of a single drop can vary with the viscosity of the solution, the design of the dropper, and patient technique. The average volume of a drop is 35-50 microliters, but can be as high as 75 microliters. An eye brimming with fluid holds 30 microliters at best, so even one drop is often an overdose. A second either washes out the first or increases the possibility of systemic toxicity,...

The gram-positive anaerobic bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea. The antibiotics most often implicated have been ampicillin, second and third generation cephalosporins, clindamycin and fluoroquinolones. The emergence in recent years of a new, more toxic epidemic strain (BI/NAP1), possibly related to widespread use of fluoroquinolones, has caused a marked increase in the incidence and severity of C. difficile-associated disease (CDAD).

The FDA has approved two new ophthalmic drugs for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension: latanoprostene bunod (Vyzulta – Bausch and Lomb), a modified prostaglandin analog, and netarsudil (VRhopressa – Aerie), the first Rho kinase inhibitor to be approved in the US.

The FDA has approved daridorexant (Quviviq – Idorsia), an orexin receptor antagonist, for treatment of sleep-onset and/or sleep-maintenance insomnia in adults. Daridorexant is the third orexin receptor antagonist to be approved for this indication; suvorexant (Belsomra) and lemborexant (Dayvigo) were approved earlier.

In June 2021, the FDA approved the IV amyloid beta-directed monoclonal antibody aducanumab (Aduhelm) for treatment of Alzheimer’s disease. The approval did not restrict use of the drug to patients with mild cognitive impairment or mild dementia, which was the population enrolled in the clinical trials. Now, Biogen, with the permission of the FDA, has made an addition to the labeling of the drug that says: Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical...

About 2.5 million persons in the US had hepatitis C between 2017 and 2020. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA) on management of hepatitis C virus (HCV) infection were updated in 2023.