Takeda's top oncology prospect is moving toward approval in the European Union, as continental regulators have accepted the company's application and promised a shortened review period for the blood cancer treatment.
The oral drug, ixazomib, is designed to treat relapsed and refractory multiple myeloma, a form of cancer that begins in the blood marrow. Like Takeda'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.
The drug, another product of Takeda's $8.8 billion acquisition of Millennium Pharmaceuticals from 2008, is the company's best bet in oncology after late-stage setbacks for the lymphoma treatment alisertib and prostate cancer drug orteronel.
Takeda submitted ixazomib in the U.S. last month, and the Japanese drugmaker is planning to file more applications around the globe before the end of the year.
The drug's filings are based on Phase III data in which 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 company is running three additional Phase III trials in other multiple myeloma populations and another trial in in AL amyloidosis, a rare and deadly blood cancer for which ixazomib received the FDA's breakthrough-therapy designation last year.
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