Takeda’s myeloma drug fast-tracked in Europe

A new treatment for multiple myeloma has been granted an 'accelerated assessment' by Europe's medicines regulator.

Takeda's ixazomib is being developed to treat patients with relapsed and/or refractory multiple myeloma, and could be a major new entrant to the competitive market.

The drug is the first oral proteasome inhibitor to enter late-stage trials, and has already shown superior results to Celgene's market leading Revlimid (lenalidomide) + dexamethasone in phase III data published earlier this year.

Analysts EvaluatePharma forecast the drug could achieve $1.1 billion in sales by 2020, which would help Takeda carve out a significant presence in oncology.

The drug already has FDA Breakthrough Therapy Designation, and has been filed with the US regulator, with a decision expected within four weeks.

The EMA's accelerated assessment is similar to the FDA's Breakthrough status, being reserved for medicines deemed to be of 'major public health interest and, in particular, therapeutic innovation'.

Ixazomib (MLN9708) is also being studied in systemic light-chain (AL) amyloidosis, and other malignancies. It is also the first oral proteasome inhibitor to enter phase III clinical trials.

Andrew Plump, MD, Takeda's chief medical and scientific officer, welcomed the CHMP accelerated assessment decision, and said it underscored the urgent need for new treatments in multiple myeloma.

"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 programme."

"Continuous therapy is emerging as a standard of care in multiple myeloma because it has demonstrated improved long-term outcomes," said Philippe Moreau, MD, 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."

The drug looks likely to gain approval in the EU and the US, but will face an array of rivals in the multiple myeloma market, including Bristol-Myers Squibb and AbbVie's elotuzumab.