FDA Approves Enhertu for Some With HER2-Positive Solid Tumors

The FDA approved Enhertu for some patients with HER2-positive solid tumors who do not have other alternative treatments.

The Food and Drug Administration has granted Enhertu (fam-trastuzumab deruxtecan-nxki) an accelerated approval for certain patients with HER2-positive solid tumors.

Patients eligible for this accelerated approval include individuals who have unresectable (not surgically unremovable) or metastatic HER2-positive solid tumors who have previously received systemic treatment. Eligible patients also do not have satisfactory alternatives for treatment, according to the announcement from the FDA.

This approval is based on findings from three trials: DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02. The efficacy of the Enhertu was evaluated in 192 patients with unresectable or metastatic HER2-positive solid tumors who were previously treated and were enrolled in one of the three DESTINY trials.

The major outcome regarding efficacy in all three trials was confirmed objective response rate (ORR; patients whose tumors shrunk or disappeared from treatment). An additional efficacy outcome included duration of response (DOR; time the tumor responds to treatment).

In the DESTINY-PanTumor02 trial, the ORR was 51.4% and the median DOR was 19.4 months, the FDA’s alert stated. The ORR was 52.9% and the median DOR was 6.9 months in the DESTINY-Lung01 trial. Similarly, patients in the DESTINY-CRC02 trial demonstrated an ORR of 46.9% and a DOR of 5.5 months.

The most common side effects from Enhertu in this patient population with HER2-positive solid tumors included decreased white blood cell count, nausea, decreased hemoglobin, fatigue, decreased lymphocyte count, and decreased platelet count.

Other common side effects included increased alanine aminotransferase, increased blood alkaline phosphates, vomiting, decreased appetite, hair loss, diarrhea, constipation, decreased sodium, stomatitis and upper respiratory tract infection.

A Boxed Warning is included, which advises health professionals and patients of the risk for interstitial lung disease and embryo-fetal toxicity.

The recommended dosage for Enhertu in patients with unresectable or metastatic HER2-positive solid tumors who have previously received systemic treatment is 5.4 milligrams/kilogram. Enhertu is given intravenously once every three weeks in a 21-day cycle until the cancer worsens or has unacceptable toxicity.

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