European Commission Approves Libtayo in PD-L1-Positive Non-Small Cell Lung Cancer
The EC's approval is based on data from a Phase III trial showing a significant increase in overall survival and progression-free survival compared to placebo.
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.
CHMP Recommends Regeneron's Libtayo, Chemo for First-Line PD-L1-Positive NSCLC
The regulator recommended Libtayo plus chemo for patients with advanced NSCLC who express PD-L1 in greater than or equal to 1 percent of tumor cells.
Adding Libtayo and fianlimab to neoadjuvant chemo improved outcomes over just chemo for patients with triple-negative and HR-positive, HER2-negative breast cancer.
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.