FDA Approves First Targeted Therapy for HER2-Low Breast Cancer

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Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki) is the first targeted therapy for HER2-low breast cancer.

FDA approved Daiichi Sankyo’s Enhertu (fam-trastuzumab-deruxtecan-nxki), an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. Fam-trastuzumab-deruxtecan-nxki is the first therapy that specifically targets the HER2-low breast cancer subtype, a newly defined subset of HER02 negative breast cancer that describes breast cancers that have some HER2 proteins on the cell surface, but not enough to be classified as HER2-positive.

FDA stated in an August 5, 2022 press release that the approval is based on the findings ofDESTINY-Breast04, a randomized, multicenter, open label clinical trial that enrolled 557 adult patients with unresectable or metastatic HER2-low breast cancer. 373 randomly received fam-trastuzumab-deruxtecan-nxki, while 184 received the physician’s choice of chemotherapy — eribulin, capecitabine, gemcitabine, nab paclitaxel, or paclitaxel. The results demonstrated improvement in both progression-free survival and overall survival in patients with unresectable or metastatic HER-2 low breast cancer.

“Today’s approval highlights the FDA’s commitment to be at the forefront of scientific advances, making targeted cancer treatment options available for more patients,” said Richard Pazdur, director of FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in FDA’s Center for Drug Evaluation and Research, in the press release. “Having therapies that are specially tailored to each patient’s cancer subtype is a priority to ensure access to safe and innovative treatments.”


Source: FDA