FDA approves Takeda’s Ninlaro for multiple myeloma
pharmafile | November 23, 2015 | News story | Manufacturing and Production, Research and Development | Takeda, myeloma
The US Food and Drug Administration (FDA) has approved Takeda’s Ninlaro (ixazomib) for use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma, who have received at least one prior therapy.
The once-weekly pill is the first and only oral proteasome inhibitor- a class of therapy that destroys cancer cells by blocking the proteasome and by inhibiting protein metabolism. Ixazomib is believed to be particularly effective against multiple myeloma, as myeloma cells have higher levels of proteasome activity than normal cells.
Takeda submitted a New Drug Application (NDA) for Ninlaro to the FDA in July 2015, and the drug was granted Priority Review status in September.
The final approval will come as welcome news for the Japanese company, which has sought a replacement revenue source for its blockbuster proteasome inhibitor Velcade (bortezomib), which will go off-patent in the US in the second quarter of 2017 and has faced increasing competition from Amgen’s Kyprolis (carfilzomib).
The FDA approved Ninlarois based on results from the TOURMALINE-MM1 Phase 3 clinical trial- the first double-blind, placebo-controlled trial with a proteasome inhibitor. Patients in TOURMALINE-MM1 received in a ratio of 1:1 either the combination of ixazomib, Celgene’s Revlimid (lenalidomide) and the steroid dexamethasone; or the combination of placebo, lenalidomide and dexamethasone.
TOURMALINE-MM1 is the first of five ongoing Phase 3 clinical trials in the TOURMALINE program, which has enrolled approximately 3,000 patients to-date in 40 countries.
“With the approval of Ninlaro, we can now offer patients a once-weekly oral proteasome inhibitor as part of a highly active triplet therapy,” says Paul Richardson, clinical program leader and director of Clinical Research, Jerome Lipper Multiple Myeloma Center. “We, as investigators of the TOURMALINE-MM1 trial, felt it was vital to conduct a comprehensive ‘real world’ evaluation of this combination that included some of the most common patient types in the relapsed/refractory multiple myeloma setting, such as older patients, patients with moderate renal impairment, light chain disease, and high risk cytogenetics.
“Further, we treated patients until disease progression to determine the sustainability of Ninlaro in treating their relapsed/refractory disease. The TOURMALINE-MM1 data demonstrate convincingly that oral Ninlaro-based triplet treatment is effective at extending progression-free survival, over and above the clinical benefit seen with lenalidomide and dexamethasone, with a tolerable safety profile.”
Andy Plump, Takeda chief medical and scientific officer, comments: “We introduced the first proteasome inhibitor for multiple myeloma, Velcade, into clinical research approximately 20 years ago. Since that time, we’ve significantly advanced scientific understanding of this rare cancer, culminating in the introduction of Ninlaro. Ninlaro is an entirely new molecule that offers the efficacy of this proteasome inhibitor in a convenient once-weekly pill with a tolerable safety profile. Takeda is delighted to bring this significant innovation to multiple myeloma patients today, and we continue to examine the potential of Ninlaro through a robust clinical development program.”
Dr Brian Durie, chairman of the International Myeloma Foundation, adds: “The IMF is pleased by the approval of ixazomib. This opens the door for a fully oral proteasome inhibitor-based triplet combination therapy. Having worked in multiple myeloma for decades, I’ve seen notable progress, yet significant unmet needs remain. With today’s approval, we now have another attractive option for many patients living with multiple myeloma.”
Joel Levy
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