Imlunestrant Combo Makes ESR1 Testing a Selection Step

FDA approved imlunestrant plus abemaciclib for ESR1-mutated, ER-positive, HER2-negative advanced breast cancer, requiring FDA-authorized biomarker testing to establish eligibility following endocrine therapy progression.

FDA approved once-weekly insulin efsitora alfa-gobe for adults with type 2 diabetes, offering fewer injections while requiring careful attention to hypoglycemia, dosing and monitoring.

FDA granted accelerated approval for dostarlimab in eligible stage II or III locally advanced rectal cancer, based on clinical complete response and durability evidence.

FDA classified Medline’s recall of convenience kits containing potentially Aspergillus-contaminated ChloraPrep applicators as Class I, requiring inventory quarantine, product destruction, and recall documentation.

FDA approved talazoparib plus enzalutamide for HRR-mutated metastatic prostate cancer sensitive to androgen-pathway modulation, requiring mutation confirmation through an FDA-authorized test.

A conference review examines isotope-specific dosimetry, manufacturing, supply, and safety challenges across alpha- and beta-emitting radiopharmaceuticals, emphasizing evidence-based development without cross-cancer efficacy rankings.

FDA granted accelerated approval for dostarlimab in selected MSI-H or dMMR locally advanced rectal cancer, offering potential organ preservation through immunotherapy and structured surveillance.

FDA granted traditional approval for pembrolizumab in eligible TMB-high solid tumors, retaining requirements for advanced disease, prior treatment progression, and no satisfactory alternatives.

FDA expanded pirtobrutinib approval to previously untreated CLL or SLL, adding a first-line option while preserving individualized treatment timing and selection among established alternatives.

FDA approved imlunestrant plus abemaciclib for ESR1-mutated advanced breast cancer, requiring biomarker confirmation through an FDA-approved test, with Guardant360 CDx designated companion diagnostic.