Merck Nabs Full FDA Approval for Keytruda in MSI-High, dMMR Solid Tumors
The conversion from accelerated to full approval marks the first time the FDA has granted full approval to an immunotherapy in a tumor-agnostic indication.
Astellas Bullish on Zolbetuximab's Prospects in Gastric Cancer After Two Positive Phase III Readouts
The firm will submit data from the GLOW and SPOTLIGHT studies to regulators and seek approval for zolbetuximab plus chemo in CLDN18.2-positive HER2-negative advanced gastric cancer.
Novartis Nets FDA Approval for Tafinlar-Mekinist in Pediatric Low-Grade Glioma
Regulators approved Novartis' BRAF/MEK inhibitor combo for kids whose tumors harbor BRAF V600Emutations and simultaneously approved a new liquid form of the treatment.
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.
FDA Approves Gilead's Trodelvy for HR-Positive, HER2-Negative Metastatic Breast Cancer
The approval expands the antibody-drug conjugate's use beyond triple-negative breast and urothelial cancer and includes patients whose tumors express hormone receptors.