Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration granted approval to pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 [Tumor Proportion Score (TPS) >=1%], as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. The product label further states that patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

This is written in the approval document as:

KEYTRUDA is a programmed death receptor-1 (PD-1)-blocking antibody indicated as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS >=1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Citation

Merck Sharp & Dohme Corp. Keytruda (pembrolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125514s174lbl.pdf. Revised April 2025. Accessed April 30, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 1%	Non-Small Cell Lung Cancer	Pembrolizumab