FDA as­sem­bles ad­comm to re­view GSK's Jem­per­li tri­al plans in rec­tal can­cer

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee will meet this Thurs­day to dis­cuss whether pro­posed stud­ies would sup­port an ac­cel­er­at­ed ap­proval for GSK’s Jem­per­li in rec­tal can­cer — de­spite ini­tial con­cerns about the tri­al plans.

GSK’s PD-1 block­er Jem­per­li, al­so known as dostar­limab, was first ap­proved back in 2021 for a spe­cif­ic sub­set of re­cur­rent or ad­vanced en­dome­tri­al can­cer pa­tients who have a ge­net­ic fea­ture called dMMR, or de­fi­cient mis­match re­pair. The la­bel was ex­pand­ed months lat­er to in­clude all adults with dMMR re­cur­rent or ad­vanced sol­id tu­mors who have pro­gressed or stag­nat­ed on ear­li­er ther­a­py.

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