FDA Approves Jazz's Bispecific HER2 Antibody Ziihera, With and Without BeOne's Tevimbra, for First-Line HER2-Positive Gastroesophageal Adenocarcinoma
HERIZON-GEA-01 put the three-drug arm past two years of median survival against trastuzumab and chemotherapy. The label splits the two regimens by HER2 score, and Roche's 4B5 antibody and Dual ISH probe were approved as the companion tests the same day.
FeaturedJohnson & Johnson Turned Rybrevant's Survival Win Into a Once-a-Month Injection, With More Planned for Amivantamab
Seventeen months after MARIPOSA showed that Rybrevant plus Lazcluze extends life in first-line EGFR-mutated lung cancer, J&J has cut the infusion to a five-minute shot, moved dosing to once a month and carried the antibody into head and neck cancer. Second-quarter sales rose 61%.
Cover StoryAstraZeneca Rebuilds Breast Cancer Treatment Around Enhertu, Datroway and a Blood Test
Three US approvals between December and May moved Enhertu into curative-intent HER2-positive disease and put Datroway ahead of chemotherapy for triple-negative patients who cannot get immunotherapy. The camizestrant review, extended by the FDA without a new date after a 3-to-6 advisory vote, is still open.
