Conditional Approval Urged in EU for Trastuzumab Deruxtecan

Conditional Approval Urged in EU for Trastuzumab Deruxtecan
The Committee for Medicinal Products for Human Use (CHMP), an arm of the European Medicines Agency, has recommended the conditional approval of trastuzumab deruxtecan (DS-8201) for the treatment of patients with inoperable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens. The therapy, which has received accelerated assessment in Europe, already has been approved in Japan and in the U.S., under the trade name Enhertu. The U.S. approval was granted after trastuzumab deruxtecan was granted priority review by the Food and Drug Administration. The CHMP positive opinion will now be reviewed by the European Commission, which will decide whether to grant conditional approval. Trastuzumab deruxtecan, developed by Daiichi Sankyo in collaboration with AstraZeneca, is an antibody-drug conjugate that targets cells carrying the HER2 protein. This conjugate is made of an HER2-specific antibody and deruxtecan, a cancer-killing agent. It is a potential treatment for all types of HER2-positive cancers, including metastatic ones that have spread to other parts of the body. “We are encouraged by the CHMP positive opinion given the significant unmet need for patients with HER2 positive metastatic breast cancer,” Gilles Gallant, PhD, Daiichi Sankyo's senior vice president and global head of oncology R&D, said in a press release. “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,” Gallant said. CHMP’s positive recommendation was based on results from the Phase 2 DESTINY-Breast01 trial (NCT03248492) and from a Phase 1 open label tr
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