The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the conditional approval of ixazomib capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.

The FDA has already approved ixazomib for treatment of multiple myeloma in the US.

If the European Commission ratifies the CHMP’s opinion and authorisation is granted, ixazomib will be the first oral proteasome inhibitor approved for use across the European Economic Area, which includes the 28 member states of the European Union as well as Norway, Liechtenstein and Iceland.

These approvals have been based on the results of the TOURMALINE-MM1 trial, reported at ASH 2015 here.

“This is great news and a very positive development for myeloma patients in Europe,” said Eric Low, Chief Executive, Myeloma UK, and Board Member, Myeloma Patients Europe. “The improvement in progression free survival in this difficult-to-treat stage of myeloma is significant. In addition to ixazomib’s efficacy in this relapsed and/or refractory group of patients, its manageable safety profile and oral administration makes ixazomib a very welcome new treatment option for this serious and complex cancer. It is important that attention is now turned in earnest to the Health Technology Assessment bodies to ensure their approval of ixazomib.’’

Data from the pivotal Phase 3 trial TOURMALINE-MM1 demonstrate that the addition of ixazomib to lenalidomide and dexamethasone provides a significant improvement in progression-free survival when compared to placebo plus lenalidomide and dexamethasone in relapsed / refractory multiple myeloma patients who have received one to three prior therapies.

Patients continue to be treated to progression in the trial, with additional evaluations planned for long-term outcomes such as overall survival.

Source: EMA