FDA Accepts Keytruda Application for Earlier NSCLC After Surgery

The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.

The FDA has accepted for review Merck’s supplemental biologics license application (sBLA) seeking approval for Keytruda (pembrolizumab) for the adjuvant treatment of patients with stage IB, II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection.

The FDA has set a Prescription Drug User Fee Act (PDUFA) date of Jan. 29, 2023. But Merck indicated in a press release that additional data may be provided during the review process that may delay this date.

The sBLA is based on data from the pivotal phase 3 KEYNOTE-091 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC) and the European Thoracic Oncology Platform (ETOP). The study has dual primary endpoints of disease-free survival in both patients with and without PD-L1 tumor expression.

In an interim analysis, Keytruda showed improvement in DFS for patients regardless of PD-L1 expression compared with placebo but in patients whose tumors express PD-L1, Keytruda did not reach statistical significance. The trial will continue to analyze DFS in patients whose tumors express high levels of PD-L1.

Lung cancer is the leading cause of cancer death worldwide. In 2020 alone, there were more than 2.2 million new cases and 1.8 million deaths from lung cancer globally. Non-small cell lung cancer is the most common type of lung cancer, accounting for about 82% of all cases. In the United States, the overall five-year survival rate for patients diagnosed with lung cancer is 24%.

Keytruda is approved for several indications in non-small-cell lung cancer, including

  • in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.
  • in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.
  • as a single agent for the first-line treatment of patients with NSCLC expressing PD-L1 with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic
  • as a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1, with disease progression on or after platinum-containing chemotherapy.