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03-05-2017 | Regorafenib | Drug approval | Article


Regorafenib approved for liver cancer, midostaurin for AML

medwireNews: FDA approval for regorafenib has been expanded to include patients with hepatocellular carcinoma that has previously been treated with sorafenib.

Regorafenib was previously approved for the treatment of metastatic colorectal cancer and gastrointestinal stromal tumors that are no longer responsive to earlier treatment. The further approval has been granted following results from the phase III trial RESORCE, which demonstrated better overall and progression-free survival with regorafenib versus placebo for patients with disease progression after sorafenib.

The oral multikinase inhibitor should be given at a dose of 160 mg/day after a low-fat meal for the first 21 days of a 28-day cycle.


The multikinase inhibitor midostaurin has received FDA approval for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) positive for the FLT3 mutation. Midostaurin should be used alongside standard cytarabine and daunorubicin induction therapy and cytarabine consolidation.

The LeukoStrat CDx FLT3 Mutation assay has been approved as a companion diagnostic for midostaurin in AML patients.

Finally, patients with aggressive systemic mastocytosis alone or alongside hematologic neoplasm or mast cell leukemia may also now use the drug.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2017 Springer Healthcare part of the Springer Nature group

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