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Novartis announced today that the United States Food and Drug Administration has granted Breakthrough Therapy designation to PKC412 (midostaurin). PKC412 (midostaurin) is an investigational treatment for adults with newly-diagnosed 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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Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

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