FDA Approves Enhertu for Subset of Patients with Metastatic Breast Cancer


The FDA’s approval of Enhertu in this setting, according to an expert, marks an important milestone and will allow patients with unresectable or metastatic HER2-positive breast cancer to be treated in an earlier line, with the possibility of delaying disease progression.

The Food and Drug Administration (FDA) has approved treatment with Enhertu (fam-trastuzumab – deruxtecan-nxki) for patients with unresectable or metastatic HER2-positive breast cancer.

The agency gave the green light to the indication of Enhertu in patients who have received a prior HER2-based regimen in either the metastatic setting or in the neoadjuvant (delivered before the main treatment, such as surgery, to reduce the size of the tumor) or adjuvant setting (administered after the primary treatment to kill any remaining cancer cells) and developed disease recurrence within six months after therapy.

The approval is based on results from the DESITNY-Breast03 phase 3 trial which demonstrated a 72% reduced risk of disease progression or death with Enhertu in this patient population.

“Enhertu has demonstrated significant progression-free survival in the earlier metastatic setting, potentially establishing it as a new standard of care in previously treated patients with HER2-positive metastatic breast cancer,” Dr. Erika Hamilton, director of the Breast Cancer and Gynecological Cancer Research Program at Sarah Cannon Research Institute in Nashville, Tennessee, said in a press release. “Today’s approval is an important milestone for the clinical community as we will now be able to offer Enhertu to these patients earlier in their treatment.”

Previously, Enhertu was granted accelerated approval by the FDA. This approval now broadens the drug’s ability to treat patients with HER2- positive metastatic breast cancer in an earlier line.

“This is an important day for the breast cancer community,” said Catherine Ormerod, executive vice president of Strategy and Mission at Living Beyond Breast Cancer, in the release.

“With this approval, Enhertu now provides a new treatment option for patients with HER2-positive metastatic breast cancer which can be used earlier in treatment to potentially delay progression of disease,” Ormerod concluded.

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