Revumenib

Sonrotoclax, BeiGene’s next-gen inhibitor, targets WT and mutated Bcl-2 by binding within a hydrophobic groove, addressing first-gen limitations.

The FDA approved revumenib, a first-in-class menin inhibitor, for treating acute leukemias with a KMT2A translocation. Based on the AUGMENT-101 trial, 21.2% of patients achieved complete remission or complete remission with partial hematopoietic recovery. The recommended dose is 270 mg orally twice a day for patients weighing 40 kg or more, with adjustments for body surface area and CYP3A4 inhibitors.

November 2024 saw numerous FDA approvals, designations, and clinical trial advancements in oncology, including revumenib for KMT2A-rearranged acute leukemia, obe-cel for relapsed/refractory B-cell ALL, and fast track designations for ALE.P02 in Claudin-1-positive tumors. Other highlights include orphan drug designations for LBL-024 in neuroendocrine cancer and elraglusib in Ewing sarcoma, and a new drug application for sunvozertinib in EGFR-mutant NSCLC.

SELLAS Life Sciences Group identifies ASXL1 mutation as key predictor of SLS009 response in solid cancers, with 67% efficacy observed in ASXL1 mutated cancers vs 0% in non-mutated cancers. ASXL1 mutations were found in colorectal cancer (CRC MSI-H) and non-small cell lung cancer (NSCLC), supporting targeted SLS009 clinical trials.

Negotiations for FY 2025 appropriations are ongoing, impacting NIH funding; President-elect Trump's nominees for HHS, CMS, CDC, FDA, and Surgeon General spark concern in the medical research community; House Appropriations Subcommittee reviews NIH budget for FY 2025; AACR and FDA host workshops on DPD deficiency and clinical trials; U.S. Surgeon General highlights tobacco use disparities; FDA approves new drugs and updates product labeling.

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.