Bristol-Myers Squibb Co. said the Japanese Ministry of Health, Labor, and Welfare has approved Opdivo (nivolumab) for unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy.
FDA granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies.
FDA approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer.
Regeneron Pharmaceuticals Inc. and Sanofi said FDA has granted Breakthrough Therapy designation status to cemiplimab, an investigational human, monoclonal antibody targeting PD-1– (REGN2810) for the treatment of adults with metastatic cutaneous squamous cell carcinoma and adults with locally advanced and unresectable CSCC.
The European Commission approved Merck's Keytruda (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma.
Cellect Biotechnology Ltd. said the FDA has granted orphan drug designation for Cellect's ApoGraft for the prevention of acute and chronic graft versus host disease in transplant patients.
Genentech, a member of the Roche Group, said FDA has accepted the company's supplemental Biologics License Application and granted priority review for Gazyva (obinutuzumab) in combination with chemotherapy followed by Gazyva alone for people with previously untreated follicular lymphoma.
FDA approved Besponsa (inotuzumab ozogamicin) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.The agent is sponsored by Pfizer Inc.
Kymriah (tisagenlecleucel) became the first gene therapy available in the United States.
FDA approved Mylotarg (gemtuzumab ozogamicin) for the treatment of adults with newly diagnosed acute myeloid leukemia whose tumors express the CD33 antigen (CD33-positive AML).
