The FINANCIAL — Takeda Pharmaceutical Company Limited on November 24 announced that the European Commission has granted conditional marketing authorization for NINLARO （ixazomib） capsules, indicated in combination with lenalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior therapy.
The decision to approve NINLARO as the first and only oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency （EMA） Committee for Medicinal Products （CHMP） for Human Use in September 2016.
“For myeloma patients living in Europe, the approval of NINLARO means we have a new and effective treatment option available when we relapse,” said Bob Munro, a patient with multiple myeloma from the United Kingdom. “I applaud the European Commission for recognising 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. I strongly hope this will be made available by national health systems across Europe as soon as possible.”
The European Commission followed the CHMP’s recommendation to approve NINLARO based on data from the pivotal Phase 3 TOURMALINE-MM1 trial, which demonstrated that NINLARO plus lenalidomide and dexamethasone increased the length of progression-free survival by about six months, or 40 percent, in patients with relapsed and refractory multiple myeloma when compared with placebo, lenalidomide and dexamethasone. The study also showed that the progression-free survival benefit observed in the NINLARO regimen extended across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017, according to Takeda.
“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,” said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. “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.”
“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, M.D., President, 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. 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.”
As a result of the European Commission decision, NINLARO is now approved for use across the European Economic Area, which includes the European Union’s 28 member states as well as Norway, Liechtenstein and Iceland. In addition, NINLARO is licensed for use in the U.S., Canada, Israel, Australia and Venezuela, and Takeda has submitted marketing authorization applications for NINLARO to a number of additional regulatory authorities around the world.
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