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FDA approves blockbuster PD-1 therapy combination for first-line treatment of esophageal cancer BMS

 Last Update: 2022-08-10
 Source: Internet
 Author: User

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Bristol-Myers Squibb (BMS) announced that the US FDA has approved two treatment regimens based on the blockbuster PD-1 inhibitor Opdivo (nivolumab, nivolumab) (Opdivo in combination with fluoropyrimidine and platinum-containing chemotherapy; Opdivo and Anti-CTLA-4 antibody Yervoy) as first-line therapy for the treatment of advanced unresectable, or metastatic esophageal squamous cell carcino.

Esophageal cancer is one of the leading causes of cancer death in the world, and China is a country with a high incidence of esophageal canc.

This approval is based on positive results from the Phase 3 clinical trial CheckMate-64 The trial results showed that the Opdivo chemotherapy combination significantly improved the overall survival of patients and reduced the risk of death by 26% compared with chemotherapy (HR=74, p=002

Among all randomized patients, median overall survival was 12 months in the Opdivo chemotherapy group and 17 months in the chemotherapy gro.

The Opdivo/Yervoy combination also significantly improved overall survival compared with chemothera.

References:

[1] US Food and Drug Administration Approves Two Opdivo® (nivolumab)-Based Regimens as First-Line Treatments for Unresectable Advanced or Metastatic Esophageal Squamous Cell Carcino.

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