TOKYO & MUNICH– 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.1
Following review of the application under its accelerated assessment procedure, the Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on results from the pivotal phase 2 DESTINY-Breast01 trial, which were published in TheNew England Journal of Medicine, and the results from the phase 1 trial published in TheLancet 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 now one step closer to bringing this important new medicine to patients in Europe.”
“The durable responses demonstrated in the DESTINY-Breast01 trial have never been seen before in this patient setting,” said José Baselga, MD, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “If approved by the European Commission, physicians in Europe will have an important new treatment option for patients with previously treated HER2 positive metastatic breast cancer.”
The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to grant marketing authorizations for medicines in the EU.
