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FDA Updates for January 2025
On January 27, 2025, the FDA approved fam-trastuzumab deruxtecan-nxki (ENHERTU®, DSI / AZ) for the treatment of adult patients with unresectable or metastatic HR-positive, HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting based on DESTINY-Breast06 (NCT04494425). The FDA granted a label expansion approval for Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, a companion diagnostic, to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU. Read More
On January 24, 2025, the FDA provided the following to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients. Read More
On January 21, 2025, the FDA approved treosulfan (Grafapex, medac GmbH), an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients 1 year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) based on the MC-FludT.14/L Trial II (NCT00822393). Read More
On January 17, 2025, the FDA approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.), a Trop-2-directed antibody and topoisomerase inhibitor conjugate, for adult patients with unresectable or metastatic, HR-positive, HER2-negative (IHC 0, IHC1+ or IHC2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the TROPION-Breast01 trial (NCT05104866). Read More
On January 16, 2025, the FDA approved sotorasib (Lumakras, Amgen Inc.) with panitumumab (Vectibix, Amgen Inc.) for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy based on the CodeBreaK 300 trial (NCT05198934). The FDA also approved the therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) as a companion diagnostic device to aid in identifying patients with colorectal cancer whose tumors harbor KRAS G12C mutations and who may be eligible for Lumakras with Vectibix. Read More
On January 16, 2025, the FDA granted traditional approval to acalabrutinib (Calquence, AstraZeneca) with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT) based on the ECHO trial (NCT02972840). The FDA also granted traditional approval to acalabrutinib as a single agent for adults with previously treated MCL. Acalabrutinib receivedExternal Link Disclaimer accelerated approval for this indication in 2017. Read More
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