Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan Flufenamide Withdrawal, Teclistamab Biweekly Dosing, Linvoseltamab in RRMM

New FDA Approvals

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Enmetazobactam for cUTI: The FDA approved enmetazobactam (Exblifep) for complicated urinary tract infections (cUTIs) in adults, offering a new weapon against antimicrobial-resistant gram-negative bacteria. It's combined with cefepime, based on successful phase 3 trial results, and is expected to hit the US market soon, addressing the needs of approximately 3.6 million US patients annually. Orchid Pharma receives approval, highlighting the drug's priority review status due to its Qualified Infectious Disease Product designation. Dupilumab for COPD: Dupilumab (Dupixent) is under priority review by the FDA as a novel biologic therapy for certain adults with uncontrolled chronic obstructive pulmonary disease (COPD), based on promising phase 3 trials. It targets interleukin signaling involved in COPD's inflammatory process, potentially reducing exacerbations and improving lung function over time. If approved, it would be a significant advancement for COPD treatment, offered by Regeneron Pharmaceuticals and Sanofi.

Melphalan Flufenamide Withdrawal: The FDA has withdrawn approval for melphalan flufenamide (Pepaxto) for certain multiple myeloma patients due to a lack of confirmed clinical benefit and safety concerns, marking the first application of new procedures for accelerated approval withdrawal. The decision follows the Food and Drug Omnibus Report Act amendments, concluding a process allowing manufacturer Oncopeptides an appeal opportunity. Teclistamab Biweekly Dosing: Teclistamab-cqyv (Tecvayli) receives FDA approval for biweekly dosing in relapsed or refractory multiple myeloma patients who have maintained a complete response for six months, enhancing treatment flexibility. This approval is based on the phase I/II MajesTEC-1 study, demonstrating maintained responses and safety with the new dosing schedule, highlighting fewer severe infections and no new safety concerns.

Linvoseltamab in RRMM: The FDA has granted priority review to the biologics license application for linvoseltamab for treating adult patients with relapsed or refractory multiple myeloma after at least three prior therapies. Targeted for an August 2024 decision, linvoseltamab aims to enhance T-cell activation against cancer cells, supported by promising results from the ongoing LINKER-MM1 trial, offering a new therapeutic option from Regeneron.

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