pointed to the potential for trastuzumab deruxtecan to address unmet need. “This is really, really compelling data,” he said. The ADC mechanism of delivering therapy “right to the source ...

We also need to understand mechanisms for resistance to trastuzumab deruxtecan as a single agent so we can develop combination therapies to further improve outcomes in this setting.” Trastuzumab ...

FDA has granted priority review status to trastuzumab deruxtecan (Enhertu ... 1 The deadline for FDA action is May 30, 2024. 2 A tumor-agnostic approval would be a significant development in ...

Trastuzumab deruxtecan plus pertuzumab showed significant improvement in PFS compared with taxane chemotherapy plus ...

October 01, 2024--(BUSINESS WIRE)--AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for ENHERTU ® (fam-trastuzumab deruxtecan ... the FDA action date for ...

Trastuzumab deruxtecan-THP was associated with a statistically significant and clinically meaningful improvement in pathologic complete response rate vs standard of care. The DESTINY-Breast11 ...

A regulatory decision is expected during the first quarter of 2025. The Food and Drug Administration has accepted for Priority Review the supplemental Biologics License Application (sBLA) for ...

and we look forward to continuing to work with our partners within the drug reimbursement ecosystem to unlock additional mechanisms for accelerating access to more medicines in the future." ...

Positive results from the DESTINY-Breast09 Phase III trial showed ENHERTU ® (fam-trastuzumab deruxtecan-nxki) plus pertuzumab demonstrated a highly statistically significant and clinically ...