Approval was based on results from the randomized phase 3 CheckMate-214 study.
Improvement in RFS was seen regardless of PD-L1 status.
At surgery, blood samples were taken from 163 patients; whole genome sequencing and whole exome signaling were performed on detected CTCs.
Improvements in alopecia were, however, seen in 37 of 46 patients treated with topical minoxidil.
The recommended phase 2 dose is 800 mg twice daily.
The FDA is reviewing a New Drug Application, which is requesting full approval for CLL/SLL and accelerated approval for follicular lymphoma.
Changes in access to care from 2010 to 2016 were evaluated.
Per-cycle, PLD cost $2509, bevacizumab cost $7585, and pembrolizumab cost $9026.