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NEW YORK (GenomeWeb) – Merck announced this evening that it has received approval from the US Food and Drug Administration for its anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1.

In conjunction with that approval, Agilent Technologies also announced that its Dako PD-L1 IHC 22C3 pharmDx assay has received expanded approval to act as a companion diagnostic for Keytruda in this new indication.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.