FDA approves 1st targeted HER2-low breast cancer therapy

The FDA approved Enhertu Aug. 6, the first targeted therapy for HER2-low breast cancer.

Enhertu is an IV infusion for the treatment of patients with unresectable or metastatic HER2-low breast cancer. It received priority review and breakthrough therapy designations after the success of  DESTINY-Breast04, a randomized, multicenter, clinical trial that enrolled 557 adult patients with unresectable or metastatic HER2-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, MD, director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "Having therapies that are specially tailored to each patient's cancer subtype is a priority to ensure access to safe and innovative treatments."

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