(1)
Exploratory biomarker analyses from an ongoing phase 1 study of Daiichi Sankyo Company, Limited s (hereafter, Daiichi Sankyo) patritumab deruxtecan, a HER3 directed DXd antibody drug conjugate (ADC), in patients with previously treated EGFR-mutated metastatic/unresectable non-small cell lung cancer (NSCLC) were highlighted in a poster presentation today at the IASLC 2020 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of Lung Cancer.
Lung cancer is the leading cause of cancer death among both men and women, and accounts for about one-fifth of all cancer deaths globally, with 80 to 85 percent classified as NSCLC.
1,2 For patients with metastatic disease, prognosis is particularly poor, as only 6 to 10 percent live beyond five years after diagnosis.
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 cases of breast cancer in women are diagnosed annually, with an estimated one in five cases being HER2 positive. 1,2,3 The impact of the disease is significant, with breast cancer responsible for more than 141,000 deaths per year in Europe. 1
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 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.
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 now one st