FDA Approves Takeda’s Ninlaro to Treat Multiple Myeloma

November 30, 2015

The FDA has given Takeda’s Ninlaro the green light of approval in combination with other therapies to treat multiple myeloma in the second-line setting.

The approval comes months ahead of the March 10, 2016, PDUFA date. The FDA earlier granted priority review and orphan drug designations for Ninlaro (ixazomib), a proteasome inhibitor that blocks enzymes from multiple myeloma cells, hindering their ability to grow and survive. It is the first once-weekly oral proteasome inhibitor.

Ninlaro is approved in combination with Celgene’s Revlimid (lenalidomide) and corticosteroid dexamethasone.

The approval was supported by a Phase 3 trial in 722 patients with multiple myeloma who did not respond to previous treatment. Patients received either Ninlaro in combination with lenalidomide and dexamethasone or placebo plus lenalidomide and dexamethasone. Patients on the study drug lived longer without their disease worsening — on average 20.6 months — than those in the placebo arm (14.7 months).

Ninlaro is the third drug for multiple myeloma approved this year, the FDA says. Novartis’ Farydak (panobinostat) was approved in February, while Janssen’s Darzalex (daratumumab) got the FDA’s green light earlier this month.

Takeda is pricing a 28-day cycle of treatment at a list price of $8,670, which is comparable to Velcade, Takeda said. It will be available in the first half of December.