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France General , San Antonio , United States , Dave Fredrickson , Daiichi Sankyo , Fabrice Andr , Daiichi Sankyos , Head Of Research , Daiichi Sankyo Company , Oncology Development , World Health Organization , European Commission , Clinical Development Program , Department Of Medical Oncology , Daiichi Sankyo Group , European Union , Daiichi Sankyo Company Ltd , European Medicines Agency , Professor Fabrice Andr , Medical Oncology , Gustave Roussy Cancer Campus , Antonio Breast Cancer , New England Journal , Gilles Gallant , Senior Vice President , Global Head ,

ENHERTU® Approved in the EU for the Treatment of HER2 Positive Metastatic Breast Cancer

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 ....

France General , San Antonio , United States , Dave Fredrickson , Masashi Kawase , Daiichi Sankyo , Daiichi Sankyo Europe Gmb , Fabrice Andr , Melo Gagliato , Head Of Research , Daiichi Sankyo Company , Oncology Development , Daiichi Sankyo Inc , European Commission , World Health Organization , Clinical Development Program , Daiichi Sankyo Co Ltd , Department Of Medical Oncology , Daiichi Sankyo Group , European Union , European Medicines Agency , Daiichi Sankyo Company Ltd , National Comprehensive Cancer Network , Sankyo Company , Professor Fabrice Andr , Medical Oncology ,

Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer - Press Release

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 ....

United States , Masashi Kawase , Daiichi Sankyo , Daiichi Sankyo Europe Gmb , Trastuzumab Deruxtecan , Melo Gagliato , Plexxikon Inc , Daiichi Sankyo Inc , Daiichi Sankyo Company , Oncology Development , World Health Organization , European Commission , Drug Administration , Trastuzumab Deruxtecan Clinical Development Program , Daiichi Sankyo Co Ltd , European Union , Daiichi Sankyo Group , Committee For Medicinal Products Human Use , National Comprehensive Cancer Network , Business Wire , Medicinal Products , Human Use , Thenew England Journal , Antonio Breast Cancer Symposium , Gilles Gallant , Senior Vice President ,

Daiichi Sankyo Company, Limited: Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for HER2 Positive Metastatic Breast Cancer

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. ....

United States , Masashi Kawase , Daiichi Sankyo , Daiichi Sankyo Europe Gmb , Trastuzumab Deruxtecan , Melo Gagliato , Plexxikon Inc , Daiichi Sankyo Inc , Daiichi Sankyo Company , Oncology Development , World Health Organization , European Commission , Drug Administration , Trastuzumab Deruxtecan Clinical Development Program , Daiichi Sankyo Co Ltd , European Union , Daiichi Sankyo Group , Committee For Medicinal Products Human Use , National Comprehensive Cancer Network , Sankyo Company , Medicinal Products , Human Use , Thenew England Journal , Antonio Breast Cancer Symposium , Gilles Gallant , Senior Vice President ,