AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
The designation for HCB101covers all forms of gastric cancer, including advanced gastric adenocarcinoma in both HER2-positive and HER2-negative patients
The drug, currently in a phase 1b/2 clinical trial for small cell lung cancer, is a polymer nanoparticle formulation of SN-38
OS is a key secondary endpoint of the 948-patient study, which is evaluating whether adding AstraZeneca's PD-L1 inhibitor to standard FLOT chemotherapy
New findings reveal bemarituzumab plus chemotherapy significantly improves survival in advanced gastric cancer, offering hope for targeted treatment options
Third approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu in less than two years
Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone
If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
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