On Wednesday, April 11, 2019, the FDA approved pembrolizumab (Keytruda), an immunotherapy treatment that can be used for the first-line treatment of patients with stage III non-small cell lung cancer (NSCLC).

This indication expands treatment options available for PD-L1 positive NSCLC patients (with EGFR or ALK mutations) who are not candidates for surgery or chemoradiation. Previously, pembrolizumab was FDA approved only in combination with chemotherapy for metastatic NSCLC.

This latest approval stems from the findings of the KEYNOTE-042 clinical trial. Study participants in the trial had statistically significant overall survival in those who received pembrolizumab versus those who received chemotherapy alone. This was seen across all levels of PD-L1 expression making pembrolizumab a critical addition to the treatment options available for this patient group. Find out more at this link.