Ninlaro Granted Conditional Approval by European Commission to Treat Multiple Myeloma

The European Commission has granted conditional marketing authorization to Ninlaro (ixazomib) capsules in combination with Revlimid (lenalidomide) and Decadron (dexamethasone) for multiple myeloma patients who have received at least one prior therapy.

Ninlaro’s approval was based on results from the TOURNALINE-MM1 Ohase 3 trial and follows a positive opinion issued by the European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) in September. The drug is now approved for use in the U.S., the European Union’s 28 member states, as well as Norway, Iceland, and Liechtenstein.

“With the approval of Ninlaro by the European Commission, physicians across the region will have the option to prescribe an all-oral triplet regimen to treat patients with multiple myeloma who have received at least one prior therapy,” Philippe Moreau, MD, head of the Hematology Department at the University Hospital of Nantes, France, said in a press release.

“In the TOURMALINE-MM1 study, we saw a clinically meaningful six-month improvement in progression-free survival with Ninlaro, evidence that has supported its approval in Europe. As a hematologist, I welcome the availability of this treatment to address a devastating disease like multiple myeloma,” Moreau said.

The randomized, double-blind, multicenter TOURMALINE-MM1 (NCT01564537) study was designed to determine the safety and effectiveness of adding oral Ninlaro to the background therapy of Revlimid and Decadron. The study enrolled 722 multiple myeloma patients and led to Ninlaro’s approval in November 2015 for the same indication in the U.S.

Results of the study were published April 2016 in The New England Journal of Medicine.

Results showed that adding Ninlaro to Revlimid and Decadron in patients who had received at least one prior therapy increased their median progression free survival by about six months, or 40 percent, compared to a control group who received a placebo plus Revlimid and Decadron. A follow-up analysis for overall survival is now expected in 2017.

“When developing Ninlaro, Takeda Oncology’s scientists sought to formulate an efficacious and unique oral proteasome inhibitor with a manageable safety profile. Ninlaro delivers the proven efficacy of a proteasome inhibitor in a convenient once-weekly pill that can be taken at home,” said Christophe Bianchi, MD, president of Takeda Oncology.

“Ninlaro has the potential to help European patients with relapsed multiple myeloma by removing some of the barriers that can stand in the way of optimal treatment,” he added. “With Ninlaro, our hope is that many patients will be able to continue therapy until disease progression. Following the European Commission’s approval, we will continue to study Ninlaro in a variety of settings in the hopes that we can bring this medicine to as many of the patients who may benefit from it as possible.”

Bob Munro, a patient with multiple myeloma from the United Kingdom, said Ninlaro’s approval means patients in Europe have a “new and effective treatment option available when we relapse.”

“I applaud the European Commission for recognizing the additional benefit that Ninlaro will bring to patients, who not only want treatment options that are effective and tolerable, but also appreciate the convenient option of taking an oral treatment,” Munro said. “I strongly hope this will be made available by national health systems across Europe as soon as possible.”