BMS’s Opdivo On Track For Esophageal Cancer Indication
Opdivo showed a 23% fall in the risk of death and 2.5-month improvement in median overall survival compared to chemotherapy in Phase III esophageal cancer trial.
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Keeping Track: US FDA Approvals Include Novel Agents Zepzelca And Uplizna, Biosimilar Nyvepria, Follow-On Semglee
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
EU and US regulators have opposing views when it comes to Merck's applications for a new indication and new dosing schedule for the company's successful PD-1 inhibitor Keytruda.
A Phase III study testing Keytruda monotherapy in second-line esophageal cancer versus physician’s choice of chemotherapy shows a 31% reduction in risk of death for patients expressing PD-L1. [Editor's Note: Article updated to clarify trial outcomes.]