FDA Approves Trastuzumab Deruxtecan for HER2+ Breast Cancer – OncLive

The FDA has granted an accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu; DS-8201) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received ≥2 prior anti–HER2-based regimens in the metastatic setting.

The approval is based on findings from the phase II DESTINY-Breast01 trial, updated data of which were presented at the 2019 San Antonio Breast Cancer Symposium.2 In the study, trastuzumab deruxtecan induced a confirmed objective response rate (ORR) of 60.3% per independent central review (ICR; 95% CI, 52.9-67.4), including a 4.3% complete response (CR) rate, and a 56% partial response (PR) rate. Sixty-seven patients had stable disease (SD; 36.4%), and 3 with progressive disease (PD; 1.6%). Two patients were not evaluable. ORRs were consistent across subgroups, including those with prior treatment with pertuzumab (Perjeta; 64%) and those with ≥ 3 prior regimens (59%).

“There have been many advances in the development of drugs for HER2-positive breast cancer since the introduction of Herceptin (trastuzumab) in 1998. The approval of Enhertu represents the newest treatment option for patients who have progressed on available HER2-directed therapies,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, stated in a press release. “Drug development in the area of targeted therapies builds on our scientific understanding of malignant diseases not only in breast cancer, but in multiple other diseases.”

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