FDA Alerts

The FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 10-3 that efficacy findings from the phase 2 IGNYTE trial of RP1 (vusolimogene oderparepvec) plus nivolumab are clinically meaningful, supporting the investigational...

The FDA granted Priority Review to subcutaneous amivantamab and hyaluronidase for previously treated patients with recurrent or metastatic head and neck squamous cell carcinoma, supported by results from the phase 1b/2 OrigAMI-4 trial.

The FDA accepted for review a New Drug Application for daraxonrasib in adults with previously treated metastatic pancreatic ductal adenocarcinoma based on the phase 3 RASolute 302 trial, which demonstrated improvements in overall survival,...

The FDA accepted the new drug application for mezigdomide plus carfilzomib and dexamethasone for relapsed or refractory multiple myeloma based on phase 3 SUCCESSOR-2 results demonstrating a significant progression-free survival benefit...

The FDA accepted the new drug application for varegacestat for adults with progressing desmoid tumors following positive results from the phase 3 RINGSIDE trial, supporting the investigational oral gamma secretase inhibitor as a potential new...

The FDA issued a safety alert regarding tazemetostat, citing an increased risk of hematologic second primary malignancies observed in the ongoing SYMPHONY-1 trial.

Based on results from the SERENA-6 trial, the FDA’s Oncologic Drugs Advisory Committee has voted that camizestrant plus CDK4/6 inhibition does not demonstrate a favorable benefit-risk profile in patients with HR-positive, HER2-negative...

Based on results from the phase 3 CAPItello-281 trial, the FDA’s Oncologic Drugs Advisory Committee has voted that capivasertib plus abiraterone and ADT demonstrates a favorable benefit-risk profile in PTEN-deficient metastatic...

Based on data from the phase 1/2 CARDINAL study, the FDA has granted breakthrough therapy designation to TERN-701 for previously treated Ph-positive chronic myeloid leukemia.

Ipsen has voluntarily withdrawn tazemetostat from all approved indications after emerging safety findings from the confirmatory phase 1b/3 SYMPHONY-1 trial identified an unfavorable risk-benefit profile, prompting discontinuation of ongoing...