Agilent CDx for Keytruda Gets FDA Approval for Cervical Cancer

June 13, 2018
Agilent CDx for Keytruda Gets FDA Approval for Cervical Cancer
Agilent Technologies’ Dako PD-L1 IHC 22C3 pharmDx assay has become the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with Merck & Co.'s cancer immunotherapy Keytruda (pembrolizumab). [Agilent Technologies]

The FDA has approved an additional use for Agilent Technologies’ Dako PD-L1 IHC 22C3 pharmDx assay, expanding its approvals to include another indication for the multi-indication Merck & Co.’s blockbuster anti-programmed cell death protein 1 (PD-1) cancer immunotherapy Keytruda (pembrolizumab).

Dako PD-L1 IHC 22C3 pharmDx is now the first FDA-approved IHC test for determining programmed death-ligand 1 (PD-L1) expression in cervical cancer, as well as the first FDA-approved companion diagnostic to identify patients with cervical cancer for treatment with Keytruda.

“PD-L1 is a critical biomarker for identifying patients who are likely to derive benefit from anti-PD-1 immunotherapy, and with an increasingly complex marketplace, pathologists look to Agilent as the clear leader to provide accurate and reliable PD-L1 testing,” Sam Raha, president of Agilent's Diagnostics and Genomics Group, said in a statement.

Dako PD-L1 IHC 22C3 pharmDx was originally developed by Dako in conjunction with Merck, and in 2015 received FDA approval as a companion diagnostic for non-small cell lung cancer (NSCLC). In September 2017, Dako PD-L1 IHC 22C3 pharmDx won additional FDA approval as a companion diagnostic for gastric or gastroesophageal junction adenocarcinoma.

In addition to NSCLC and gastric and cervical cancers, Keytruda is approved for numerous indications related to melanoma, head and neck squamous cell cancer, classical Hodgkin lymphoma, urothelial carcinoma, and microsatellite instability-high (MSI-H) or mismatch repair deficient tumors.

It was in MSI-H or mismatch repair deficient solid tumors where Merck in May joined Foundation Medicine in announcing a collaboration to develop a companion diagnostic (CDx) for use with Keytruda in the indication. The diagnostic will be built using its existing FoundationOne CDx, which was approved late last year by the FDA across all solid tumors.

Agilent cited growth in its companion diagnostics business as one of many factors that accounted for an 11% increase in revenues for its “Diagnostics and Genomics” segment during the six months ended April 30, which is the first half of the company’s current fiscal year. Those revenues grew to $404 million from $365 million in the first half of FY 2017, according to Agilent’s Form 10-Q for its second fiscal quarter, filed May 31.