FDA expands Keytruda's NSCLC indications

Merck said FDA approved Keytruda pembrolizumab as monotherapy for first-line treatment of metastatic non-small cell lung cancer (NSCLC) and advanced NSCLC in patients who are not candidates for surgical resection or definitive chemoradiation. Patients' tumors must have ≥1% PD-L1 expression without EGFR or anaplastic lymphoma kinase (ALK) aberrations.

Keytruda was previously approved as a monotherapy for first-line treatment of metastatic NSCLC patients with high PD-L1 expression (≥50%)...