An­oth­er one bites the dust: Bris­tol My­ers Squibb pulls 'dan­gling' ac­cel­er­at­ed ap­proval for Op­di­vo in liv­er can­cer

Bris­tol My­ers Squibb has agreed to pull a sec­ond-line liv­er can­cer in­di­ca­tion for its block­buster Op­di­vo as a monother­a­py, be­com­ing the sec­ond PD-(L)1 in­di­ca­tion to bite the dust af­ter the FDA’s on­col­o­gy ad­comm re­viewed six “dan­gling” ac­cel­er­at­ed ap­provals in April.

The out­side ex­perts vot­ed against two of the six in­di­ca­tions dis­cussed at the meet­ing, in­clud­ing Op­di­vo as a monother­a­py for he­pa­to­cel­lu­lar car­ci­no­ma (HCC) pa­tients who have pre­vi­ous­ly been treat­ed with so­rafenib, and Mer­ck’s Keytru­da as a third-line treat­ment for stom­ach can­cer. The ad­comm vot­ed 5 to 4 not to main­tain Op­di­vo’s in­di­ca­tion, af­ter it failed to show clin­i­cal ben­e­fit in a con­fir­ma­to­ry tri­al.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER