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.
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Rumors that Clovis is going to be an M&A target soon are on the rise after a second thumbs-up in Europe for the firm's PARP inhibitor Rubraca, this time as maintenance therapy for platinum-sensitive ovarian cancer in all-comers.
US FDA’s Information First Policy: PD-1 Bladder Cancer Alert Aligns With Complementary Diagnostics Perspective
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.
Public Company Edition: Strategies diverge in obesity as Vivus restructures debt and raises cash for a new deal and new focus, after Orexigen nears a sale of the company via bankruptcy court. Also, Clovis leads recent offerings, while layoffs are on the table at Catabasis.