zanidatamab
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On August 25, 2026, the FDA approved the HER2 bispecific antibody zanidatamab-hrii (Ziihera) for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Two regimens were cleared: zanidatamab with tislelizumab plus fluoropyrimidine and platinum chemotherapy for patients with IHC 3+ or IHC 2+/ISH+ disease, and zanidatamab with chemotherapy alone for IHC 3+ patients. The approvals rest on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented at the 2026 ASCO annual meeting. Under the BeOne Medicines collaboration, Zymeworks has received $81 million, with up to $144 million in further milestones and tiered royalties of up to 19.5%, alongside a $250 million non-recourse Royalty Pharma financing secured on part of those royalties.
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- mp.weixin.qq.comPickBeiGene HERIZON-GEA-01: Zanidatamab Plus Tislelizumab and Chemo Extends OS in HER2-Positive Gastroesophageal Adenocarcinoma, Difference Versus Zanidatamab Plus Chemo Not Significant
In the Phase 3 HERIZON-GEA-01 trial from BeiGene, zanidatamab combined with tislelizumab and chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma achieved a median overall survival of 27.0 months. The difference versus the zanidatamab plus chemotherapy group did not reach statistical significance.
- mp.weixin.qq.comPickFDA Approves Zanidatamab Combination as First-Line Treatment for HER2-Positive Gastroesophageal Adenocarcinoma
On August 25, 2026, the FDA approved the HER2 bispecific antibody zanidatamab for first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma confirmed by an FDA-approved test. One approval covers zanidatamab combined with tislelizumab plus fluoropyrimidine and platinum chemotherapy for patients with HER2-positive disease defined as IHC 3+ or IHC 2+/ISH+. The approvals were based on the HERIZON-GEA-01 study.
- mp.weixin.qq.comPickFDA approves Ziihera for first-line HER2-positive gastroesophageal adenocarcinoma, triggering milestones and $250 million Royalty Pharma financing
The FDA on August 25, 2026 approved Ziihera (zanidatamab-hrii) for first-line unresectable locally advanced or metastatic HER2-positive gastroesophageal adenocarcinoma: IHC 3+ and IHC 2+/ISH+ patients can receive it with tislelizumab plus chemotherapy, and IHC 3+ patients with chemotherapy alone. Under the BeOne Medicines collaboration, Zymeworks has received $81 million, with up to $144 million in further milestones and tiered royalties of up to 19.5%. The approval triggers the structure set up on March 2, 2026, when Zymeworks BC moved 30% of future Ziihera royalties into Zymeworks Royalty Limited Partnership, which borrowed $250 million in non-recourse notes from Royalty Pharma secured solely on those royalties.
- mp.weixin.qq.comPickFDA approves Ziihera plus tislelizumab regimens for first-line HER2-positive gastroesophageal adenocarcinoma
The US FDA approved two first-line treatment regimens combining Jazz Pharmaceuticals' HER2 bispecific antibody Ziihera (zanidatamab-hrii) with tislelizumab, a PD-1 antibody originally developed by BeiGene, on August 25. The approval adds tislelizumab to first-line combination treatment for HER2-positive gastroesophageal adenocarcinoma in the United States. The approval covers two distinct Ziihera-based regimens.
- mp.weixin.qq.comPickFDA Approves Tislelizumab Plus Zanidatamab and Chemo for First-Line HER2-Positive Gastroesophageal Adenocarcinoma
BeiGene said the FDA has approved a supplemental application for its PD-1 antibody tislelizumab (BaiZeAn) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma. Results were published earlier this year in the New England Journal of Medicine. The material cites five-year survival below 30 percent for gastric cancer and about 19 percent for esophageal adenocarcinoma.
- mp.weixin.qq.comPickFDA Approves BeiGene's Tevimbra Plus Zanidatamab and Chemotherapy for First-Line HER2-Positive GEA
The FDA has approved BeiGene's supplemental application for Tevimbra (tislelizumab) in combination with zanidatamab and chemotherapy as first-line treatment for adults with locally advanced unresectable or metastatic HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma (GEA). About 20% of GEA patients are HER2-positive, a subtype that has long been difficult to treat.
- mp.weixin.qq.comPickFDA approves BeiGene tislelizumab with zanidatamab and chemotherapy for first-line HER2-positive gastroesophageal adenocarcinoma
The US FDA approved a new indication for tislelizumab on August 26, 2026, combining it with zanidatamab plus chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). The approval covers patients regardless of PD-L1 expression and is the first approved regimen pairing a HER2 bispecific antibody with a PD-1 inhibitor. It rests on the HERIZON-GEA-01 trial, published in the New England Journal of Medicine and presented orally at the 2026 ASCO annual meeting.
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