Opdivo sBLA Under Priority Review for New Melanoma Indication
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted for filing and has granted Priority Review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.
The sBLA submission includes data from CheckMate -066, which evaluated Opdivo in treatment-naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC).
Opdivo, a human programmed death receptor-1 (PD-1) blocking antibody, is already indicated for treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. It is also approved for metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
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