The European Commission has approved AVEO Oncology's Fotivda (tivozanib) for the treatment of adult patients with advanced renal cell carcinoma in the European Union plus Norway and Iceland.
The European Commission approved Rydapt (midostaurin) for use in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adults with newly diagnosed acute myeloid leukemia who are FLT3 mutation-positive.
FDA approved a lower dose of Jevtana (cabazitaxel, 20 mg/m2 every 3 weeks) in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. Cabazitaxel (25 mg/m2 every 3 weeks) was approved for this indication in 2010.
The European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for Tesaro's marketing authorization application for Zejula (niraparib) as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete response or partial response to platinum-based chemotherapy. This opinion will now be referred to the European Commission, which grants marketing authorization for medicines in the European Union. Pending the decision by the EC, Zejula would be the first oral, once-daily poly (ADP-ribose) polymerase 1/2 inhibitor approved in Europe for use in patients regardless of BRCA mutation or biomarker status.
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.
