In November, the FDA approved three new drugs, including obe-cel for adult B-cell acute lymphoblastic leukemia, revumenib for acute leukemia with a gene translocation, and zanidatamab for HER2-positive biliary tract cancer. The FDA also approved a liquid formulation of imatinib for leukemia and other cancers. Drug labeling for fludarabine phosphate was updated to include new indications and dosage information. The FDA is investigating bluebird bio’s gene therapy Skysona for potential blood cancer risks. Clinical trial holds on CAR T-cell products by CARsgen Therapeutics Holdings Limited were lifted, while Roche’s phase 3 study on tiragolumab did not meet its primary endpoint for non-small cell lung cancer survival.
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Last Month in Oncology: FDA Cancer News Roundup
