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Drugs & Targets

FDA grants Breakthrough Designation to PKC412 (midostaurin)

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FDA granted Breakthrough Therapy designation to PKC412 (midostaurin), 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. The designation is primarily based upon results from the phase III RATIFY clinical trial. This study was conducted...

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