Agilent Technologies (A) announced that the U.S. FDA has approved its Dako PD-L1 IHC 22C3 pharmDx assay for expanded use. Physicians in the United States can now gain valuable information to help them identify cervical cancer patients who are most likely to benefit from treatment with KEYTRUDA, an anti-PD1 immunotherapy manufactured by Merck (MRK). PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining PD-L1 expression in cervical cancer and is the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with KEYTRUDA. This follows an initial FDA approval for PD-L1 IHC 22C3 pharmDx in non-small cell lung cancer and a subsequent expanded approval to include gastric or gastroesophageal junction adenocarcinoma.
