US regulators grant breakthrough therapy for AML treatment

19 Feb 2016

Novartis received breakthrough therapy designation from the U.S. FDA for an investigational treatment for newly-diagnosed FLT3-mutated acute myeloid leukemia, the Swiss drug maker announced.

Patients who received PKC412, also called midostaurin, combined with standard induction and consolidation chemotherapy experienced what Novartis called "a significant improvement in overall survival".


With the announcement, Novartis's drug discovery program keeps pace with crosstown rival Roche, which this week won FDA breakthrough therapy designation for its ocrelizumab investigational therapy for primary progressive multiple sclerosis.‚Äč

Source: Reuters

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