Roche Gets Expanded CE Mark for Ventana PD-L1 Assay to ID NSCLC Patients for Tecentriq
The test gained European approval to identify PD-L1-expressing non-small cell lung cancer patients eligible for treatment with Roche's checkpoint inhibitor.
Roche Nabs FDA Label Expansion for Ventana CDx Panel
The immunohistochemistry companion diagnostic helps identify patients with solid tumors that are deficient in DNA mismatch repair.
FDA Approves GlaxoSmithKline's Jemperli, Roche’s Ventana CDx for dMMR Solid Cancers
The approval expands the label for GSK's anti-PD-1 agent dostarlimab, which the FDA initially approved in April for patients with dMMR endometrial cancers.
FDA Expands Approval of Pfizer's Lorbrena to First-Line ALK-Positive NSCLC; Approves Roche CDx
Based on full approval from the FDA based on the Phase III CROWN trial, Pfizer can now market the drug as a front-line option for ALK-positive NSCLC patients.
Roche's Tecentriq Nabs EC Approval in Triple-Negative Breast Cancer, Ventana Expands Use of CDx
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.