Pembrolizumab Is FDA-Approved as First-Line for PD-L1—Positive NSCLC

Patients newly diagnosed with non—small cell lung cancer (NSCLC) that expresses the programmed death ligand-1 (PD-L1) protein now have a new treatment option: pembrolizumab (Keytruda). The FDA has approved the drug for use as first-line treatment in a select population of patients whose tumors have been assessed for PD-L1 expression using an FDA-approved test.

The expanded approval, which comes less than 2 months after Merck filed a supplemental Biologics Application for pembrolizumab, adds the following indications:

1. Patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] greater than or equal to 50%), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations and no prior systemic chemotherapy treatment for metastatic NSCLC.
2. Patients with metastatic NSCLC whose tumors express PD-L1 (TPS greater than or equal to 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 pembrolizumab.

Based on the data submitted by the company, the recommended dose for pembrolizumab is 200 mg intravenously, every 3 weeks.