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).
FDA granted regular approval to olaparib tablets (Lynparza) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. FDA granted this application Fast Track status.
Ocugen Inc. said FDA has granted orphan drug designation for OCU300 (brimonidine tartrate) for the treatment of ocular graft versus host disease.
