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Lancet Oncology. In the DESTINY-Breast01 trial, trastuzumab deruxtecan demonstrated clinically meaningful and durable activity in patients who had received two or more prior anti-HER2 therapies. The safety and tolerability profile of trastuzumab deruxtecan seen in DESTINY-Breast01 was consistent with that observed in the phase 1 trial. An updated analysis from DESTINY-Breast01, reinforcing the durable efficacy and long-term safety and tolerability profile of trastuzumab deruxtecan, was presented earlier this week at the 2020 San Antonio Breast Cancer Symposium (SABCS). “We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer,” said Gilles Gallant, BPharm, PhD, FOPQ, Senior Vice President, Global Head, Oncology Development, Oncology R&D, Daiichi Sankyo. “Trastuzumab deruxtecan is already available for patients with HER2 positive metastatic breast cancer in the U.S. and Japan, and we are n ....
Daiichi Sankyo Company, Limited: Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca s trastuzumab deruxtecan has been recommended for conditional marketing authorization in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens. In Europe, approximately 520,000 cases of breast cancer in women are diagnosed annually, with roughly one in five cases being HER2 positive. 1,2 The impact of the disease is significant, with breast cancer responsible for more than 137,000 deaths per year. ....