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Press release content from Business Wire. The AP news staff was not involved in its creation. ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer January 20, 2021 GMT Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU ® (trastuzumab deruxtecan) has been granted conditional approval in the European Union (EU) as a 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 531,000 case...

Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with previously treated disease AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s trastuzumab deruxtecan has been recommended for conditional marketing authorisation in the European Union (EU) as a 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 r...

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...

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 r...