Takeda cancer drug gets EMA boost
pharmafile | July 29, 2015 | News story | Research and Development, Sales and Marketing | Takeda, ixazomib, multiple myeloma
The EMA has granted Takeda an accelerated assessment for its multiple myeloma drug, ixazomib.
The Agency’s Committee for Medicinal Products for Human Use (CHMP) awarded ixazomib an accelerated assessment, having decided it is a medicine it believes to be therapeutic innovation, in an area of major public health interest.
Ixazomib is an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma – a cancer of the plasma cells found in the bone marrow.
Takeda expects to submit a marketing authorisation application for ixazomib in the European Union in the coming weeks. The submission is based on the results of the first pre-specified interim analysis of the pivotal Phase III trial TOURMALINE-MM1.
“We are pleased that the CHMP has granted accelerated assessment for ixazomib, and believe that this designation underscores the urgent need for therapeutic innovation in multiple myeloma treatments,” says Andrew Plump, Takeda’s chief medical and scientific officer.
“We look forward to sharing the TOURMALINE-MM1 study data from the first pre-specified interim analysis at an upcoming medical meeting, and greatly appreciate the ongoing dedication and commitment from the patients and their families who have been participating in the ixazomib clinical development program.”
The ongoing trial of 722 patients is studying ixazomib plus lenalidomide and dexamethasone, compared with placebo plus lenalidomide and dexamethasone, in adult patients with relapsed and/or refractory multiple myeloma.
“Continuous therapy is emerging as a standard of care in multiple myeloma because it has demonstrated improved long-term outcomes,” says Dr Philippe Moreau, from the University Hospital of Nantes in France. “If ixazomib is approved, for the first time physicians will have the option of an all-oral proteasome inhibitor-based regimen for the treatment of multiple myeloma, which could be a real advantage in delivering sustained therapy.”
Yasmita Kumar
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