Takeda Pharmaceutical Company Limited has recently received a negative opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which recommended against authorizing NINLARO (ixazomib) capsules for relapsed and/or refractory multiple myeloma.
Takeda plans to request a re-evaluation of the CHMP opinion.
In a press release, Dr. Christophe Bianchi, president of Takeda Oncology, said the company will continue efforts and work closely with the agency to make Ninlaro “the first oral proteasome inhibitor” available in Europe.
“Despite recent progress, myeloma remains an intractable disease, and patients suffering from multiple myeloma and their treating physicians need more options to improve outcomes. We stand behind the TOURMALINE-MM1 trial data, which were recently published in the New England Journal of Medicine and demonstrated a significant extension in progression-free survival for NINLARO + lenalidomide and dexamethasone vs. placebo + lenalidomide and dexamethasone and a favorable benefit-risk profile,” Bianchi said in the release.
Dr. Philippe Moreau, of the University of Nantes, France, said Ninlaro would fill a void in Europe where no oral proteaseome inhibitor is currently available. It would be the first all-oral triplet combination therapy for patients with relapsed or refractory multiple myeloma
“After years of treating patients, I have yet to see two people whose diseases are exactly alike. The diversity of patients with multiple myeloma demands a wide range of innovative treatment options that offer efficacy, tolerable safety profiles and convenience, which are especially important benefits for elderly populations,” Moreau said.
In November 2015, the U.S. Food and Drug Administration (FDA) granted approval for Ninlaro (ixazomib) in combination with two other therapies (lenalidomide and dexamethasone) to treat people with multiple myeloma who had received at least one prior therapy. The FDA decision marked the first global regulatory approval of Ninlaro, which blocks enzymes from multiple myeloma cells, hindering their ability to grow and survive.
Takeda also has submitted approval applications for Ninlaro to other regulatory authorities around the world based on the results of the TOURMALINE-MM1 trial in relapsed and refractory multiple myeloma. The drug is being examined in other multiple myeloma treatment settings.