FDA Expands Approval for Merck’s Keytruda in NSCLC

The FDA has approved Merck’s blockbuster drug Keytruda (pembrolizumab) as a single agent for adjuvant treatment in adult patients with stage IB, II or IIIA nonsmall-cell lung cancer (NSCLC) following surgical resection and platinum-based chemotherapy.

The approval was based on phase 3 clinical trial data that demonstrated a 27 percent reduced risk of disease recurrence or death and median disease-free survival of 58.7 months.

The drug is also indicated for other forms of NSCLC, including as first-line treatment in NSCLC that expresses PD-L1 and is either stage III, where patients are not candidates for surgical resection or definitive chemoradiation, or is metastatic.

With multiple approvals in 19 different forms of cancer, Keytruda sales topped $17 billion in 2021.