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FDA Approves PD-LI Diagnostic Assay

Companion product to Keytruda

Publish date:: October 13, 2015

In parallel with the approval of Keytruda, the FDA has also given premarket approval to the PD-L1 IHC 22C3 pharmDx kit. The kit consists of a new companion diagnostic assay that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of treatment. Dako developed PD-L1 IHC 22C3 pharmDx in partnership with Merck, maker of the anti-PD-1 therapy Keytruda (pembrolizumab). Keytruda is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay and who have disease progression on or after platinum-containing chemotherapy.

Citation: Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer. [news release]. Glostrup, DK: Dako; October 5, 2015. http://www.dako.com/us/index/aboutdako/newsevents/news/pd-l1-ihc-22c3-press-release.htm#.VhfiFflViko. Accessed October 8, 2015.

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