Zanidatamab in Previously-Treated HER2-Positive (HER2+) Biliary Tract Cancer (BTC): Overall Survival (OS) and Longer Follow-up From the Phase 2b HERIZON-BTC-01 Study
Zanidatamab is a HER2-targeted bispecific antibody that binds to two non-overlapping HER2 domains and crosslinks neighboring HER2 proteins. In the primary analysis of the phase 2b HERIZON-BTC-01 trial (NCT04466891), after a median follow-up of 12.4 months, zanidatamab showed encouraging antitumor activity with rapid and durable responses and a manageable safety profile in patients with previously treated HER2+ BTC.
The FDA gave a CRL to the NDA seeking the approval of Orviglance for use in the detection of liver metastases in patients with severe kidney impairment.
Savolitinib received conditional NMPA approval in China for MET-amplified gastric or GEJ adenocarcinoma after prior systemic therapy, based on a 32.3% ORR.