First Immunotherapy Approval for First-Line Stage 4 Lung Cancer Treatment

On 24 October 2016, the United States Food and Drug Administration FDAapproved Pembrolizumab immunotherapy for stage 4 non-small cell lung cancer.

This is notable as the first immunotherapy approval in first-line non-small cell lung cancer (NSCLC).

Pembrolizumab (trade name Keytruda) therefore received FDA approval in stage 4 NSCLC under these conditions:

• For first-line treatment in patients with %50 or greater tumor PD-L1 expression. These patients must also lack the genomic targets of targeted drugs, EGFR or ALK genomic alterations or have received no prior stage 4 NSCLC treatment.
• Progression after one platinum-containing chemotherapy line with tumor PD-L1 expression of %1 or more. Patients with EGFR or ALK alterations may also use pembrolizumab after progression.

For details of the trial leading to first-line lung cancer approval, click here.