EP. 1: FDA Considers BLA for Pertuzumab Biosimilar HLX11 in Breast Cancer
FDA reviews biologics license application for HLX11, a biosimilar to pertuzumab, for HER2-positive breast cancer.
EP. 2: FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its prior HER2-low indication.
