Keeping Track: Approvals For Polivy, Keytruda, FDA Applause For Biosimilars
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Genentech’s Polivy To Get US FDA Panel Review For First-Line Treatment Of Diffuse B-Cell Lymphoma
But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.
CRLs In 2019: Steady In Number, But Biosimilar Performance Improves
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.
EU Approvals: J&J's Darzalex Steps Ahead With New Indication
The European Commission has approved Johnson & Johnson’s/Genmab’s CD38-targeted MAb, daratumumab, and Merck & Co’s checkpoint inhibitor, pembrolizumab, in two first-line additional indications, in multiple myeloma and head and neck cancer, respectively.