Takeda Pharmaceutical has received approval from the US Food and Drug Administration (FDA) for Ninlaro (ixazomib) capsules in combination with lenalidomide and dexamethasone to treat patients with multiple myeloma who have received at least one prior therapy.
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The first and only oral proteasome inhibitor, Ninlaro is a once-weekly pill that works by blocking enzymes from multiple myeloma cells, hindering their ability to grow and survive.
In July, the company submitted a new drug application (NDA) for Ninlaro to the FDA, and in September the drug was granted priority review status with a PDUFA date of 10 March 2016.
The approval is based on data from the first international, randomised, double-blind, placebo-controlled Tourmaline-MM1 Phase III clinical trial with a proteasome inhibitor.
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It is the first of five ongoing Phase III clinical trials as part of the Tourmaline programme, which has so far enrolled about 3,000 patients in 40 countries.
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By GlobalDataDana-Farber Cancer Institute Jerome Lipper Multiple Myeloma Center Institute Physician and Clinical Research clinical programme leader and director Paul Richardson said: "With the approval of Ninlaro, we can now offer patients a once-weekly oral proteasome inhibitor as part of a highly active triplet therapy.
"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."
A total of 722 patients were included in the Tourmaline-MM1 Phase III trial which evaluated Ninlaro plus lenalidomide and dexamethasone compared to placebo plus lenalidomide and dexamethasone in adults with relapsed and/or refractory multiple myeloma.
Results from the trial showed Ninlaro is effective in extending progression free survival (PFS) and has a manageable safety profile.
The trial achieved its primary endpoint and also showed a clinically meaningful and statistically significant prolongation in PFS at this analysis.
Image: Bone marrow aspirate showing the histologic correlate of multiple myeloma under the microscope. Photo: courtesy of KGH.
