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Daiichi Sankyo: Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Low Metastatic Breast Cancer with HR Positive and HR Negative Disease

Daiichi Sankyo Company, Limited: Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Daiichi Sankyo Company, Limited: Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for the Treatment of HER2 Positive Advanced Gastric Cancer

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 now one st

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