Pliant wins FDA Fast Track status for PLN-101095 plus Keytruda in ICI-refractory solid tumors
PLRX•FDA Fast Track designation for PLN-101095 combination
The FDA granted Fast Track designation for Pliant Therapeutics’ PLN-101095 with pembrolizumab for immune checkpoint inhibitor-refractory solid tumors.
Fast Track status can speed development via closer FDA interaction, rolling NDA submission, and potential priority review.
PLN-101095 is in the Phase 1a/1b FORTIFY trial, and data are expected in 2027.
