FDA nod for Keytruda a adjuvant treatment of NSCLC

Yesterday the US Food and Drug Administration (FDA) granted yet another approval for Merck & Co’s (NYSE: MRK) mega blockbuster checkpoint blocker Keytruda (pembrolizumab, this time for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

Merck’s best-selling drug Keytruda, which last year generated revenues of exceeded $17 billion and with sales expected hit $22 billon this year, is already cleared for marketing in various oncology settings including lung cancer indications, either alone or in combinations.

“Six years ago, Keytruda was the first anti-PD-1 therapy approved for the first-line treatment of metastatic non-small cell lung cancer and has changed the way metastatic disease is treated. Today’s approval marks the fifth indication for Keytruda in non-small cell lung cancer and the first indication for Keytruda in patients with resected stage IB (T2a ≥4 cm), II, or IIIA disease following adjuvant chemotherapy,” said Dr Gregory Lubiniecki, vice president, oncology global clinical development, Merck Research Laboratories, adding: “This is an important milestone as we continue our efforts to pursue meaningful advances for patients with non-small cell lung cancer.”