Regeneron
Agilent CDx Assay IVDR Certified to ID Cancer Patients for Keytruda, Libtayo Treatment
The clearance applies to use of the companion diagnostic to identify patients with multiple cancer types for treatment with Merck's Keytruda and Regeneron's Libtayo.
Roche Nabs FDA Approval for Ventana PD-L1 Test as CDx for Libtayo
The immunohistochemistry test is used to detect programmed death-ligand 1 protein in non-small cell lung carcinoma patients.
Roche Obtains CE Mark for Ventana PD-L1 Assay as CDx for Libtayo
The test is intended to determine which patients with non-small cell lung cancer may be eligible for treatment with Libtayo monotherapy.
Agilent Technologies Obtains CE Mark for Expanded Use of PD-L1 CDx in NSCLC
The firm said that the expanded use for its CDx will enable European pathologists to identify patients with NSCLC who may be eligible for treatment with cemiplimab.
FDA Approves Regeneron, Sanofi's Libtayo With Agilent PD-L1 CDx in Frontline NSCLC
Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.