Breast Cancer
News and reporting on breast cancer.
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.
In Brief This Week: Cullinan Oncology, Aileron Therapeutics, Sanofi, Exscientia
News items for the week of Jan. 3, 2022.
China's NMPA Begins Review of Zai Lab's Margenza for HER2-Positive Metastatic Breast Cancer
The agent is already approved in the US based on results from the Phase III SOPHIA trial comparing Margenza to Genentech's Herceptin.
Relay Therapeutics Advances Trials of PI3Kα, FGFR2 Inhibitors
The company is studying its PI3Kα inhibitor as a single agent and in combination with fulvestrant in patients with PI3Kα mutations in the first-in-human trial.
Regor Therapeutics to Begin US CDK2/4/6 Inhibitor Study for HR-Positive, HER2-Negative Breast Cancer
Following FDA clearance, the firm will assess its investigational agent, RGT-419B, as treatment for advanced HR-positive, HER2-negative breast cancer patients.