Bristol Myers Squibb’s Opdivo (nivolumab) 240 mg (injection for intravenous use) every two weeks or 480 mg every four weeks in combination with Cabometyx (cabozantinib) 40 mg once daily tablets was approved by the U.S. Food and Drug Administration for the first-line treatment of patients with advanced renal cell carcinoma.
Roche’s Venclexta Granted Full Approval Under Project Orbis and Real-Time Review
Accelerated Approval, Acute Myeloid Leukemia (AML), Adults 75 or older, Approvals, B-cell lymphoma-2 (BCL-2) protein, Chemotherapy, Clinical Trials, FDA/Regulatory, Full Approval, Project Orbis, R&D, Real-Time Oncology Review (RTOR) PilotThe U.S. Food and Drug Administration granted Roche’s Venclexta (venetoclax) full approval in combination with azacytidine, or decitabine, or low-dose cytarabine for newly diagnosed acute myeloid leukemia in adults 75 years or older.