Research & Development
FDA Approves Merck's Keytruda Plus Chemotherapy, With or Without Bevacizumab, as Treatment for Patients with Persistent, Recurrent or Metastatic Cervical Cancer Whose Tumors Express PD-L1 (CPS ≥1)
15 October 2021 - - The US Food and Drug Administration has approved Keytruda, US-based pharmaceutical company Merck's (NYSE: MRK) anti-PD-1 therapy, in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved test, the company said.

The approval is based on the Phase 3 KEYNOTE-826 trial evaluating Keytruda plus chemotherapy (paclitaxel plus cisplatin or paclitaxel plus carboplatin), with or without bevacizumab, compared to the same chemotherapy regimens, with or without bevacizumab.

In this patient population, Keytruda plus chemotherapy, with or without bevacizumab, demonstrated superior overall survival (OS; HR=0.64 [95% CI, 0.50-0.81]; p=0.0001) and progression-free survival (PFS; HR=0.62 [95% CI, 0.50-0.77]; p
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