The FDA has approved new first-line treatment options for adults with certain HER2-positive gastric, gastroesophageal junction and esophageal cancers.
The agency approved Ziihera in combination with Tevimbra and fluoropyrimidine- and platinum-containing chemotherapy for adults with HER2-positive, unresectable, locally advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma, according to an Aug. 25 FDA news release. The FDA also approved Ziihera in combination with fluoropyrimidine- and platinum-containing chemotherapy for patients who are not candidates for Tevimbra.
In a global trial, patients receiving Ziihera, Tevimbra and chemotherapy had a median overall survival of 26.4 months, compared with 19.2 months among patients receiving trastuzumab and chemotherapy. Patients went a median 12.4 months without their cancer progressing with the Ziihera combination, compared with 8.1 months with trastuzumab and chemotherapy.
The FDA also approved two companion diagnostic devices to identify patients with HER2-positive gastric, gastroesophageal junction or esophageal adenocarcinoma who may be eligible for Ziihera treatment.
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