FDA Approvals

Based on results from the ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials, the FDA has approved sacituzumab govitecan for first-line treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer as...

Based on results from the 3 PATINA trial, the FDA has approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for patients with HR-positive, HER2-positive locally...

Based on results from the SPEARHEAD-1 study, the FDA granted full approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma and expanded its indication to include eligible patients aged 12 years and older.

Based on results from the phase 3 CAPItello-281 trial, the FDA has approved capivasertib plus abiraterone and prednisone for adult patients with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is...

Based on results from the phase 3 LITESPARK-022 trial, the FDA has approved adjuvant belzutifan plus pembrolizumab for adult patients with clear cell renal cell carcinoma at intermediate- or high risk of recurrence.

The FDA has approved an orally disintegrating nilotinib formulation for adults with Ph–positive chronic myeloid leukemia that can be administered with acid-reducing agents and without food restrictions.

Based on results from the phase 3 POTOMAC study, the FDA has approved durvlaumab plus Bacillus Calmette-Guerin (BCG) for BCG-naïve patients with high-risk non-muscle invasive bladder cancer.

Based on results from the phase 2 CADENZA trial, the FDA has approved pivekimab sunirine for adult patients with blastic plasmacytoid dendritic cell neoplasms.

Based on results from the TROPION-Breast02 trial, the FDA has approved datopotamab deruxtecan for patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitor therapy.

Based on results from the phase 3 DESTINY-Breast11 and DESTINY-Breast05 trials the FDA has approved neoadjuvant and adjuvant trastuzumab deruxtecan for patients with HER2-positive early breast cancer.