Takeda Pharmaceutical’s Ninlaro has been awarded conditional marketing approval in Europe as a second-line treatment for multiple myeloma.
The drug is indicated in combination with lenalidomide and dexamethasone for adults patients with the condition who have had at least one prior therapy.
The decision, which makes Ninlaro (ixazomib) the first oral proteasome inhibitor approved to treat multiple myeloma, is based on data from the pivotal Phase III TOURMALINE-MM1 trial, which showed that the therapy increased the length of progression-free survival by around six months, or 35 percent, in patients with relapsed and refractory multiple myeloma compared to a placebo-based regimen.
According to the data seen thus far, the progression-free survival benefit observed with the Ninlaro regimen was maintained across pre-specified subgroups of patients; follow-up analyses for overall survival are planned for 2017.
“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.”
Under the conditional marketing authorisation pathway, medicines can be allowed on to the market where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required, based on the scope and criteria defined in legislation and guidelines.
Conditional marketing authorisations are reviewed annually, and are usually contingent on a specific set of requirements, such as new clinical data, with the aim of confirming the drug’s benefit’s outweigh any risks.
Ninlaro was approved in the US in November last year.
