FDA Oncology Announcements

Anti-HER2 × Gastrointestinal × Clear all

4 Announcements

FDA approves pembrolizumab for HER2 positive gastric or gastroesophageal junction adenocarcinoma expressing PD-L1 (CPS ≥1)

Trial: MK-3475-811
Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA amends pembrolizumab’s gastric cancer indication

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to tucatinib with trastuzumab for colorectal cancer

Drugs: Tukysa (tucatinib) · ERBB2 inhibitor, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

Drugs: Keytruda (pembrolizumab) · Anti-PD-1 antibody, trastuzumab · Anti-HER2 antibody
Condition: Gastrointestinal