The FINANCIAL — Takeda Pharmaceutical Company Limited announced on September 16 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the conditional approval of NINLAROTM (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.
If the European Commission ratifies the CHMP’s opinion and authorization is granted, NINLARO will be the first and only 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.
“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 NINLARO to lenalidomide and dexamethasone provides a significant improvement in progression-free survival when compared to placebo plus lenalidomide and dexamethasone in this patient population. Patients continue to be treated to progression in the trial, with additional evaluations planned for long-term outcomes such as overall survival, according to Takeda.
“The heterogeneity of multiple myeloma means that it is very important for patients and physicians to have access to a variety of treatment options, and many physicians are now looking forward to the possibility of adding NINLARO to our treatment armamentarium,” said Philippe Moreau, MD, Head of the Hematology Department at the University Hospital of Nantes, France. “The clinical data strongly support the use of NINLARO in relapsed and/or refractory patients, while also delivering the advantages of an all-oral triplet regimen. In the TOURMALINE-MM1 trial, the NINLARO regimen showed a significant improvement in progression-free survival of 35 percent when compared to the placebo regimen.”
“Today’s positive CHMP opinion for the conditional approval of NINLARO is an important first step to bringing this treatment to a relapsed and/or refractory patient population where there is a significant unmet need,” said Christophe Bianchi, M.D., President, Takeda Oncology. “Currently approved proteasome inhibitors are only available through twice-weekly injections and infusions, which can place additional logistical burdens on patients and their caregivers, who already are dealing with a difficult disease. We hope that the efficacy, convenience and manageable safety profile of this innovative treatment may allow for extended duration of treatment, which has the potential to improve patient outcomes. Thank you to the patients and investigators for their participation in the TOURMALINE-MM1 trial to further our understanding of NINLARO’s benefits.”
For a conditional approval, Takeda is required to provide post-approval updates on safety and efficacy analyses for TOURMALINE-MM1 and some other already ongoing studies to demonstrate the treatment’s long-term effects.
NINLARO received its first approval from the U.S. Food and Drug Administration in November 2015 following priority review. In the U.S., it is indicated for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy. Currently licensed for use in the U.S., Canada, Israel and Venezuela, NINLARO is also under review for approval by a number of regulatory authorities around the world. The CHMP’s positive opinion for the conditional approval of NINLARO will now be reviewed by the European Commission.
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