Enhertu Now Available for Unresectable or Metastatic HER2-Positive Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki; Daiichi Sankyo) is now available for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2-based regimens in the metastatic setting.

The approval of Enhertu, a HER2-directed antibody and topoisomerase inhibitor conjugate, was based on results from the phase 2, open-label, single-group, multicenter DESTINY-Breast01 trial that included 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received ≥2 prior anti-HER2 therapies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu is administered via intravenous (IV) infusion once every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Due to the risk of neutropenia and left ventricular dysfunction, complete blood counts and left ventricular ejection fraction should be assessed prior to treatment initiation and at regular intervals during treatment. In addition, Enhertu carries a Boxed Warning for interstitial lung disease and embryo-fetal toxicity.

The product is supplied as a preservative-free lyophilized powder for IV infusion in 100mg single-dose vials. In order to prevent medication errors, vial labels should be checked to ensure that the drug being prepared and administered is Enhertu (fam-trastuzumab deruxtecan-nxki) and not trastuzumab or ado-trastuzumab emtansine.

“We are proud that Enhertu is now available in the US nearly 4 months ahead of our original goal,” said Ken Keller, President and CEO, Daiichi Sankyo, Inc. “Physicians now have a new specifically engineered HER2-directed antibody drug conjugate with demonstrated durable efficacy that may change the way these patients are treated.”

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