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Novartis receives FDA Breakthrough Therapy designation for PKC412 (midostaurin)

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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