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FDA Updates for October 2024
On October 29, 2024, the FDA granted accelerated approval to asciminib (Scemblix, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) evaluated in the ASC4FIRST (NCT04971226) trial. Read More
On October 18, 2024, the FDA approved zolbetuximab-clzb (Vyloy, Astellas Pharma US, Inc.), a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive based on the SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials. The FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc./Roche Diagnostics) as a companion diagnostic device to identify patients with gastric or GEJ adenocarcinoma who may be eligible for treatment with zolbetuximab. Read More
On October 10, 2024, the FDA approved inavolisib (Itovebi, Genentech, Inc.) with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy based on INAVO120 (NCT04191499) trial. FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant. Read More
On October 3, 2024, the FDA approved nivolumab (Opdivo, Bristol Myers Squibb Company) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements based on CHECKMATE-77T (NCT04025879) trial. Read More
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