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FDA Approves Pembrolizumab for PD-L1+ Cervical Cancer

Jason M. Broderick @jasoncology
Published: Tuesday, Jun 12, 2018

The FDA has granted pembrolizumab (Keytruda) an accelerated approval for the treatment of patients with advanced, PD-L1–positive cervical cancer with disease progression on or after chemotherapy.

Agilent Technologies also announced in a press release today that the FDA has approved its Dako PD-L1 IHC 22C3 pharmDx assay as a companion diagnostic to identify patients with cervical cancer who are eligible for pembrolizumab based on their PD-L1 expression level. The assay had previously been approved for use in the non–small cell lung cancer and gastric or gastroesophageal junction adenocarcinoma settings.
Keytruda Prescribing Information. Accessed June 12, 2018.

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