FDA expands gastroesophageal cancer options

Phase 3 findings showed longer median progression-free survival with zanidatamab-containing regimens vs trastuzumab plus chemotherapy.

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FDA approved two first-line treatment options containing zanidatamab-hrii for HER2-positive gastroesophageal adenocarcinoma.
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Zanidatamab-hrii is indicated for patients with HER2-positive tumors that are immunohistochemistry 3-positive or 2-positive and in situ hybridization-positive.
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Both zanidatamab-containing regimens reduced the risk of disease progression or death by 35% compared to trastuzumab plus chemotherapy.
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Median overall survival with zanidatamab-hrii plus tislelizumab-jsgr was 26.4 months, compared to 19.2 months with trastuzumab plus chemotherapy.
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Diarrhea was the most common adverse reaction, with serious adverse reactions occurring in 59% of patients receiving zanidatamab-hrii with tislelizumab.

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