In further major FDA shake-ups, three top regulators left the agency on May 15, just days after the resignation of Commissioner Marty Makary.
Charles Rudin was appointed director of Memorial Sloan Kettering Cancer Center, effective June 1.
FDA’s acting drug chief, acting vaccines chief, and chief of staff ousted in the wake of Makary departure
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Albert Koong was appointed chief scientific officer at the University of Texas MD Anderson Cancer Center effective June 1.
FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials, respectively.
FDA approved Signatera CDx as a companion diagnostic for use with adjuvant atezolizumab (Tecentriq) immunotherapy in muscle-invasive bladder cancer.
FDA granted orphan drug designation to CLN-049, a novel, investigational FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia .
FDA has granted Hyrnuo (sevabertinib) priority review status for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations in patients with no prior therapy.
