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30-07-2018 | FDA | News

approvalsWatch

Ivosidenib, filgrastim biosimilar receive approvals

medwireNews: The US FDA has granted approvals for the small molecular IDH1 inhibitor ivosidenib in select patients with acute myeloid leukemia (AML) and filgrastim-aafi to reduce the risk for infection during cancer treatment.

Ivosidenib may be used for adult patients with relapsed or refractory AML who have tested positive for a susceptible IDH1 mutation; an accompanying assay for the mutation has also been approved.

The decision follows trial findings demonstrating transfusion independence and durable remission, including molecular remission, in some patients.

The drug is recommended at a dose of 500 mg/day with or without food until disease progression or unacceptable toxicity, with an advised course of at least 6 months to allow time for a clinical response. Adverse events include fatigue, leucocytosis, arthralgia, and gastrointestinal side effects.

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The FDA has given approval for use of the biosimilar leukocyte growth factor filgrastrim-aafi to reduce the risk for infection and associated neutropenia.

In patients receiving myelosuppressive chemotherapy, or induction and/or consolidation chemotherapy for AML, the recommended dose is 5 µg/kg per day, given by subcutaneous injection, a 15­-30 minute intravenous infusion, or by continuous intravenous infusion. 

Other indications include patients undergoing bone marrow transplantation or autologous peripheral blood progenitor cell collection and treatment, and those with congenital, cyclic, or idiopathic neutropenia.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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