FDA nod for Keytruda as first-line cervical cancer treatment

Notching up another indication for its mega-blockbuster anti-PD-1 therapy, the US Food and Drug Administration has now approved Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test. The drug notched up first-half 2021 sales of over $8 billion.

The FDA also granted regular approval to pembrolizumab as a single agent for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. In June 2018, the FDA had granted accelerated approval to this indication with the companion diagnostic, PD-L1 IHC 22C3 pharmDx (Dako North America Inc.).

Clinical backing