FDA Approves Takeda’s Ninlaro for Treating Multiple Myeloma
akeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has approved Ninlaro (ixazomib) capsules, the first and only oral proteasome inhibitor, indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Ninlaro is a once-weekly pill.
Takeda submitted a New Drug Application for Ninlaro to the FDA in July 2015, and in September Ninlaro was granted Priority Review status with a PDUFA date of March 10, 2016, reflecting the profound and continuing unmet need for new treatments for multiple myeloma, a devastating, relapsing and incurable rare cancer.
