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FDA Grants Approval to Enhertu for HER2-Positive Solid Tumors, Developed by AstraZeneca and Daiichi Sankyo

NextEdge Admin

05 Apr 2024

2 min 42 sec

HER2-Positive,AstraZeneca,Daiichi Sankyo

The US Food and Drug Administration (FDA) has granted accelerated approval to Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, for the treatment of patients with unresectable or metastatic HER2-positive solid tumors who have exhausted previous therapy options. Eligible patients must have HER2-overexpressing refractory solid tumors with immunohistochemistry scores of 3+.

This decision was based on findings from three Phase II trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02, involving nearly 200 patients. Across these trials, Enhertu demonstrated overall response rates of 51.4%, 52.9%, and 46.9%, respectively. In DESTINY-PanTumor02, patients experienced a median duration of response of 19.4 months, while in DESTINY-Lung01 and DESTINY-CRC02, the median durations were 6.9 months and 5.5 months, respectively. Notably, patients with certain pre-existing conditions such as interstitial lung disease, significant heart disease, or active brain metastases were excluded from these trials.

As an accelerated approval, the long-term availability of Enhertu in this indication will necessitate further confirmation of its safety and efficacy. Enhertu is already approved in the US for HER2-positive and HER2-low metastatic breast cancer, HER2-positive gastric cancer, and HER2-mutant non-small cell lung cancer.

This approval marks Enhertu’s inclusion in a growing cohort of therapies approved by the FDA based on a common biomarker across various tumor types. Other tissue-agnostic indications granted by the agency, primarily in the refractory setting, include Keytruda (pembrolizumab) for microsatellite instability-high or mismatch repair-deficient tumors and tumor mutational burden high cancers, Vitrakvi (Larotrectinib) and Rozlytrek (entrectinib) for tumors with NTRK fusions, Jemperli (dostralimab) for mismatch repair-deficient tumors, Retevmo (selpercatinib) for tumors with RET fusions, and the combination of Tafinlar and Mekinist (dabrafinibi/tramatenib) for BRAF V600E-mutated cancers.