FDA Decision Week: Summit, Cytokinetics and Teva Await Verdicts

Three FDA decisions land this week, and they cover a lot of ground: advanced lung cancer, a heart condition that restricts blood flow, and acute agitation tied to psychiatric disorders. Summit Therapeutics, Cytokinetics and Teva Pharmaceutical Industries are the companies waiting on the regulator. The news comes just days after the FDA approved Johnson & Johnson's Rybrevant Faspro for adults with recurrent or metastatic head and neck squamous cell carcinoma.

Summit's ivonescimab is the highest-stakes call. The drug, developed with China-based Akeso, targets advanced non-small cell lung cancer in patients with EGFR mutations whose disease worsened after targeted therapy, and it works by blocking both PD-1 and VEGF proteins that drive cancer cell growth. Its Phase 3 Harmoni trial hit its primary goal of improving progression-free survival, but the initial analysis missed statistical significance on overall survival. Last week Summit pushed updated data showing a 24% reduction in the estimated risk of death when ivonescimab was combined with chemotherapy versus chemotherapy alone.

Cytokinetics isn't asking for a new approval. It wants the FDA to let it add Phase 3 Maple-HCM results to the prescribing information for Myqorzo, which is already cleared for a heart condition that limits blood flow. In that trial, patients on Myqorzo logged significantly bigger gains in exercise capacity after 24 weeks than those on Metoprolol, a standard heart medication. Cytokinetics says peak oxygen consumption improved by an additional 2.3 milliliters per kilogram per minute compared with metoprolol.

Teva's piece of the week centers on IGALMI, a treatment for acute agitation associated with psychiatric disorders. The company recently picked up worldwide rights to the drug from BioXcel Therapeutics for $57.5 million, putting Teva on the hook for this week's regulatory call.