FDA Alerts

Based on emerging safety data from the SYMPHONY-1 trial, Ipsen has voluntarily withdrawn tazemetostat from all indications and markets, including follicular lymphoma and epithelioid sarcoma.

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.

Based on emerging safety data from the ongoing SYMPHONY-1 trial, Ipsen has voluntarily withdrawn tazemetostat across all approved indications.

Based on data from the phase 1b/2 OrigAMI-4 study, the FDA has granted breakthrough therapy designation to amivantamab plus hyaluronidase for patients with HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma.

Based on results from the phase 3 MANEUVER trial, the FDA accepted the New Drug Application for pimicotinib for the treatment of patients with tenosynovial giant cell tumor.