US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
Executive Summary
Tecentriq and Keytruda's apparently lower efficacy in low PD-1/L1 patients in ongoing first-line trials prompts communication instead of restriction, underscoring FDA's emerging approach to precision medicine labeling.
You may also be interested in...
Keytruda, Tecentriq Face Efficacy Questions In Urothelial Cancer
Monotherapy patients with tumors that have low PD-L1 expression experienced decrease survival in two confirmatory trials; however, the immune checkpoint inhibitors’ accelerated approvals are unlikely to be affected pending final results comparing use in combination with chemotherapy to chemo alone.
Immuno-Oncology At US FDA: Where Are The PD-1/L1 Inhibitor Applications?
Infographic guide to the almost 40 indications for burgeoning PD-1/L1 checkpoint inhibitor class either approved or under review, from the Pink Sheet's FDA Performance Tracker.
Rubraca Ovarian Cancer Maintenance Approval Brings PARP Inhibitor Parity On Broad Indication
US FDA approval of Rubraca's all-comers maintenance therapy for platinum-sensitive ovarian cancer continues model that Zejula and Lynparza used for a broad maintenance indication, with data broken out for germline BRCA mutation-positive patients in the clinical trials section of labeling.