Revumenib

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Capital Rx's November 2024 Drug Update highlights new FDA approvals: Orlynvah™ for UTIs, Emrosi™ for rosacea, Danziten™ for Ph+ CML, and Revuforj™ for acute leukemia. Expanded indications include Abrysvo™, Jylamvo™, and Scemblix™. Generic Stendra™ launched. Costs and competition noted.

Revumenib approved for R/R KMT2A-rearranged acute leukemia; datopotamab deruxtecan seeks accelerated approval for EGFR-mutated NSCLC; managing CML requires open communication; CLL patients progressing despite BTK inhibitors and venetoclax; quadruplet regimen shows improved response in transplant-eligible multiple myeloma.

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FDA approved revumenib for relapsed or refractory acute leukemia with KMT2A translocation on November 15, 2024. First administered at Florida Cancer Specialists & Research Institute, LLC (FCS) in 2019, it is now available nationwide.

On November 15, 2024, the FDA approved revumenib for relapsed or refractory acute leukemia with KMT2A translocation in patients aged 1 year and older. Efficacy was shown in a trial with a 21.2% CR+CRh rate and median duration of 6.4 months. Common adverse reactions included hemorrhage and nausea. Revumenib's availability includes an expanded access program for patients under 40 kg.

The FDA approved revumenib (Revuforj) for treating acute leukemia in patients 1 year and older, targeting KMT2A gene changes. A clinical trial showed 21% achieved complete remission lasting 6.5 months, with common side effects including bleeding and infections. 110-mg and 160-mg tablets will be available this month, with a liquid solution for patients under 40 kg available through an Expanded Access Program.

FDA approved Revuforj (revumenib), a menin inhibitor developed by Syndax, for treating relapsed or refractory acute leukemia with a KMT2A gene translocation in adults and pediatric patients. The approval was based on the AUGMENT-101 trial results, with 110 and 160 mg tablets expected to be available in November. Syndax also entered a $350 million royalty funding agreement for Niktimvo with Royalty Pharma.