Bris­tol My­er­s' Op­di­vo leads the pack with FDA ap­proval for re­sect­ed esophageal or GEJ can­cer

In a first for im­munother­a­pies, Bris­tol My­ers Squibb’s PD-1 block­buster Op­di­vo (nivolum­ab) won an­oth­er FDA ap­proval on Thurs­day, this time for the ad­ju­vant treat­ment of com­plete­ly re­sect­ed esophageal or gas­troe­sophageal junc­tion (GEJ) can­cer with resid­ual patho­log­ic dis­ease in pa­tients who have re­ceived neoad­ju­vant chemora­dio­ther­a­py.

The ap­proval is based on the re­sults from a place­bo-con­trolled, Phase III tri­al in 794 pa­tients, demon­strat­ing a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in dis­ease-free sur­vival (DFS), which was de­fined as the time be­tween ran­dom­iza­tion and the first re­cur­rence date, or death, from any cause.

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