The 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.
The U.S. Food and Drug Administration’s approval-review schedule for August includes the Biologics License Application for Bristol Myers Squibb and Juno Therapeutics’ lisocabtagene maraleucel (liso-cel) for relapsed or refractory large B-cell lymphoma after at least two previous therapies.
The U.S. Food and Drug Administration approved Roche’s immunotherapy Tecentriq in combination with the Swiss drugmaker’s Avastin for the most common kind of liver cancer.
The U.S. Food and Drug Administration approved Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) for the treatment of people with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.
The U.S. Food and Drug Administration approved Seattle Genetics’ Tukysa (tucatinib) in combination with chemotherapy agents trastuzumab and capecitabine for adults with HER2+ breast cancer that cannot be surgically removed or has metastasized to other parts of the body.
The U.S. Food and Drug Administration granted approval to Seattle Genetics Inc.’s Tukysa tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.