New FDA approval for Keytruda

The US Food and Drug Administration (FDA) has approved US pharma giant Merck & Co’s (NYSE: MRK) leading checkpoint blocker Keytruda (pembrolizumab) for the treatment of patients with resectable (tumors ≥4 centimeters [cm] or node positive) non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

With this approval, Keytruda - which notched up first-half 2023 global sales of $12.1 billion but is set to lose certain US patents towards the end of the decade – now has six indications in NSCLC, across both metastatic and earlier stages of NSCLC.

The approval was based on data from the Phase III KEYNOTE-671 trial evaluating Keytruda  in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with Keytruda as a single agent, for patients with resectable stage II, IIIA or IIIB (N2) NSCLC per the American Joint Committee on Cancer eighth edition (AJCC 8th edition).