FDA approves Ninlaro (ixazomib) + lenalidomide + dexamethasone oral combination to treat multiple myeloma- Takeda

Takeda Pharmaceutical Company Limited has announced that the 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.

The FDA approval of Ninlaro is based on results from the TOURMALINE-MM1 Phase III clinical trial, the first double-blind, placebo-controlled trial with a proteasome inhibitor. TOURMALINE-MM1 is the first of five ongoing Phase III clinical trials with study results available. The TOURMALINE program has enrolled approximately 3,000 patients to date in 40 countries. Those taking the Ninlaro combination lived longer without their disease worsening (average 20.6 months) compared to participants taking the comparison regimen (14.7 months). Data from the Ninlaro Phase III TOURMALINE-MM1 pivotal trial will be presented at the upcoming 57th Annual Meeting of the American Society of Hematology on 7th December 2015.

Comment: Ninlaro is currently under review by the European Medicines Agency (EMA) and was granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP).

Comment: Ninlaro has improved and broader activity and pharmacokinetics compared with Velcade, (bortezomib-US patent expires in 2017) which is intravenously administered whereas Ninlaro is orally administered. Ninlaro also represents competition for Kyprolis (carfilzomib), being a member of the same drug class and also an orally formulated drug that has been recently FDA approved.