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NINLARO (ixazomib) receives conditional approval from the European Commission to treat relapsed or refractory multiple myeloma

November 29, 2016 – Pharmaceutical –

Takeda UK, High Wycombe, UK, November 29, 2016 – Takeda Pharmaceutical Company Limited today announced that the European Commission has granted conditional marketing authorisation 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 ixazomib as the first 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 ixazomib means we have a new and effective treatment option available when we relapse,’ said Bob Munro, a patient representative from Myeloma UK.’I applaud the European Commission for recognising the additional benefit that ixazomib 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 CHMPís recommendation to approve ixazomib based on data from the pivotal Phase 3 TOURMALINE-MM1 trial, which demonstrated that ixazomib plus lenalidomide and dexamethasone increased the length of progression-free survival by approximately six months, or 35 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 with the ixazomib regimen was maintained across pre-specified subgroups of patients. Follow-up analyses for overall survival are planned for 2017.

Takeda Pharmaceutical Company
61 Aldwych, London, WC2B 4AE, UK