Japanese drugmaker Takeda is angling to win FDA approval for its lead cancer asset, an oral treatment for blood malignancies that is key to the company's future in oncology.
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| Takeda CEO Christophe Weber |
The Osaka-headquartered Takeda submitted its ixazomib for approval as a treatment for relapsed and refractory multiple myeloma, a form of cancer that begins in the blood marrow. The agency has 60 days to accept the application, after which it will begin a standard 10-month review before making a final decision.
Like the company's blockbuster-selling Velcade and Amgen's ($AMGN) Kyprolis, ixazomib is a proteasome inhibitor, designed to kill tumors by cutting off the production of proteins they need to grow. But ixazomib presents an oral alternative to those injected therapies, and Takeda believes it could find its way to blockbuster sales by unseating some aging competitors in hematology.
Step one is approval in relapsed and refractory multiple myeloma. In the Phase III data submitted to support approval, ixazomib beat out placebo in extending progression-free survival for multiple myeloma sufferers who have failed prior treatments. Patients received standard cancer therapies lenalidomide and dexamethasone in addition to either ixazomib or sugar pill, and those in the treatment arm lived significantly longer without their disease worsening, Takeda said.
The drugmaker is running three more Phase III trials on other populations of multiple myeloma patients and another study in AL amyloidosis, a rare and deadly blood cancer for which ixazomib received the FDA's breakthrough-therapy designation last year.
Ixazomib, another product of Takeda's $8.8 billion acquisition of Millennium Pharmaceuticals back in 2008, is the company's best bet in oncology after late-stage setbacks for the lymphoma treatment alisertib and prostate cancer drug orteronel.
Meanwhile, the storied company is entering a new era under CEO Christophe Weber, its first non-Japanese leader. Weber has promised to return Takeda to growth through a series of budget cuts and a "stringent" approach to R&D spending, vowing to learn the lessons of past clinical failures and focus only on areas where it can be a global leader.
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