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FDA grants Breakthrough Therapy status to PKC412 (midostaurin)

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ PKC412 (midostaurin). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive, as detected by an FDA-approved test, and who are eligible to receive standard induction and consolidation chemotherapy.

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