On August 11, 2022, the FDA accelerated the approval of Enhertu (fam-trastuzumab deruxtecan-nxki; from Daiichi Sankyo), a HER2-directed antibody and topoisomerase inhibitor conjugate, for the treatment of adults with unresectable (can’t be removed by surgery) or metastatic (spreading) non–small-cell lung cancer (the most common type of lung cancer) and HER2 gene mutation, as detected by an FDA-approved test.
On the same day, the FDA approved the Oncomine Dx Target Test for tissue and the Guardant360 CDx plasma test as companion diagnostics to identify patients who are candidates for receiving Enhertu. The tumor tissue test should be done if no HER2 mutation is detected with the plasma test.
Enhertu was previously approved for several solid tumors involving the HER2 biomarker.
“The approval of trastuzumab deruxtecan [Enhertu] in non–small-cell lung cancer is an important milestone for patients and the oncology community,” said Bob T. Li, MD, PhD, MPH, Memorial Sloan Kettering Cancer Center.
“After 2 decades of research into the role of targeting HER2 in lung cancer, the approval of the first HER2-directed treatment option validates HER2 as an actionable target in lung cancer and marks an important step forward for treating this patient population,” Dr. Li added.
This approval was based on results of a multicenter, randomized, double-blind clinical trial that included 52 patients with unresectable or metastatic nonsquamous non–small-cell lung cancer and HER2 mutation whose disease progressed after systemic therapy.
Overall, 58% of the patients responded to Enhertu therapy, and the average duration of response was 8.7 months.
The most common side effects reported in 20% or more of the patients receiving Enhertu were nausea, fatigue, constipation, decreased appetite, vomiting, increased alkaline phosphatase, hair loss, and many blood test abnormalities.
