Daiichi Sankyo
AstraZeneca, Daiichi Sankyo File for FDA Enhertu Approval in Second-Line HER2-Postive Breast Cancer
The agency has accepted the firms' supplemental biologics application for the antibody-drug conjugate and is expected to make a decision by Q2 2022.
EMA to Review Daiichi Sankyo, AstraZeneca's Enhertu For Second-Line HER2-Positive Breast Cancer
The EMA validated a Type II Variation Application for Enhertu in advanced, HER2-positive breast cancer patients after at least one HER2-targeted therapy.
Daiichi Sankyo, AstraZeneca Begin Phase III Trial of Enhertu in HER2-Mutant NSCLC
The study is comparing Enhertu to standard-of-care chemotherapy plus immunotherapy as a first-line treatment for advanced NSCLC patients with HER2 mutations.
AstraZeneca, Daiichi Sankyo Unveil First Datopotamab Deruxtecan TNBC Data at SABCS
The companies will conduct a Phase III trial of datopotamab deruxtecan following positive results from a Phase I TNBC cohort presented at the meeting.
In Brief This Week: Daiichi Sankyo, AstraZeneca, Mary Bird Perkins Cancer Center, Guardant Health
News items for the week of Nov. 1, 2021.