ACCC COVID-19 Resource Center & Listserv
for Insights on Providing Optimal Patient Care During the Pandemic.
bringing together oncologists and oncology-focused healthcare professionals across the Empire State
Meetings & Education
Financial Advocacy & Patient Assistance
Off-Label Use Literature
Patient Advocacy Organizations
National Professional Organizations
ESHOS Corporate Members
Become a Corporate Member
Industry News Archive
FDA Approves First-Line Pembrolizumab for Metastatic or Unresectable HNSCC
On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).
Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test. The FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting patients with HNSCC for treatment with pembrolizumab as a single agent.
Read the FDA announcement
Tweets by OSSatACCC