FDA ap­proves GSK's Jem­per­li for front­line use in cer­tain ad­vanced en­dome­tri­al can­cers

GSK’s new can­cer drug Jem­per­li (dostar­limab) won an FDA ap­proval on Mon­day, al­most two months ahead of its PDU­FA date, for use in cer­tain front­line ad­vanced en­dome­tri­al can­cers.

The PD-1, which pre­vi­ous­ly con­vert­ed an ac­cel­er­at­ed ap­proval in the US to a full ap­proval in sec­ond-line en­dome­tri­al can­cer, is now ap­proved in com­bo with car­bo­platin and pa­cli­tax­el, fol­lowed by Jem­per­li as a sin­gle agent for the treat­ment of adult pa­tients with pri­ma­ry ad­vanced or re­cur­rent en­dome­tri­al can­cer that is mis­match re­pair de­fi­cient (dMMR), as de­ter­mined by an FDA-ap­proved test, or mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H).

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