Takeda, the Japanese pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has granted Priority Review status to its New Drug Application for ixazomib as a treatment for relapsed and/or refractory myeloma patients. The application was based primarily on interim results from the pivotal Phase III TOURMALINE-MM1 trial comparing ixazomib in combination with Revlimid and dexamethasone against Revlimid and dexamethasone alone. Ixazomib is also undergoing regulatory review by the European Medicines Agency (EMA) and if approved, would be the first oral proteasome inhibitor to be available for myeloma patients.


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