RM-HNSCC
Pembrolizumab approvals
- 2014-09-04: initial approval (for melanoma progressed on ipi or BRAF TKI - KEYNOTE-002)
2016-08-05: HNSCC: monotherapy for platinum-refractory RM-HNSCC (KEYNOTE-012)
- 2017-05-23: all MSI-H/dMMR with POD and no other great tx
2019-06-10: HNSCC: +platinum + FU for all; monotherapy for CPS >=1 (KEYNOTE-048)
- 2020-06-16: all TMB >=10 with POD and no other great tx
- 2024-01-12: newest indication (pembro + CRT for stage III-IVA cervical cancer)
- Current FDA label pdf link (Drugs@FDA)
- Current FDA label web link (DailyMed)
- FDA approval announcement links: