Head and Neck Cancer

Verified discoveries, trials, and approvals for this cancer type. Every story separates evidence strength, regulatory status, and guideline position.

Latest Discoveries

FDA approves perioperative pembrolizumab for head and neck cancer — the first approval for this cancer in 6 years

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Head and Neck Cancer
Published
August 13, 2026

In the randomized, open-label, phase 3 KEYNOTE-689 trial, adding pembrolizumab before and after surgery to standard treatment significantly extended event-free survival in patients with resectable, locally advanced, PD-L1-positive head and…

Primary source cited

Last reviewed

Major Advances

FDA approves perioperative pembrolizumab for head and neck cancer — the first approval for this cancer in 6 years

Evidence stage: High-Certainty EvidenceRegulatory status: FDA Approved
Cancer type
Head and Neck Cancer
Published
August 13, 2026

In the randomized, open-label, phase 3 KEYNOTE-689 trial, adding pembrolizumab before and after surgery to standard treatment significantly extended event-free survival in patients with resectable, locally advanced, PD-L1-positive head and…

Primary source cited

Last reviewed

FDA Approvals

Regulatory approval is separate from evidence certainty and from guideline position. Approval applies only to the exact indication stated in each jurisdiction record.

FDA approves perioperative pembrolizumab for head and neck cancer — the first approval for this cancer in 6 years

Regulatory status: FDA ApprovedEvidence stage: High-Certainty Evidence
Cancer type
Head and Neck Cancer
Population
Adults with stage III-IVA resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, randomized to perioperative pembrolizumab (before and after surgery) plus standard of care, or standard of care alone, at 192 sites in North America, South America, and Europe, in the phase 3 KEYNOTE-689 trial.
View approval details
Last reviewed
2026-08-13

Regulatory status by jurisdiction

United States (FDA)

Status
FDA-approved for the exact stated cancer/use
Indication
Adults with resectable, locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1 (CPS >=1), as neoadjuvant treatment, continued as adjuvant treatment in combination with radiotherapy (with or without cisplatin), then as a single agent.
Biomarker requirement
PD-L1 CPS >=1
Decision date
2025-06-12
Source
Regulator record (opens in a new tab)

Guideline positions

Guideline

Position
Not addressed
Last verified
2026-08-13

Primary evidence supporting this story

Applies to the exact indication stated.

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Related resources

Trusted resources: official cancer information

CancerDiscoveries summarizes verified records in its database. Absence of a listing here does not establish that a treatment lacks regulatory authorization or access.