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Rubraca Ovarian Cancer Maintenance Approval Brings PARP Inhibitor Parity On Broad Indication

Executive Summary

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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EMA Restricts Rubraca’s Use Due To Concerns Over Benefit & Safety

EU doctors are being told not to prescribe Rubraca as third-line treatment for cancers of the ovary, fallopian tubes or peritoneum with a BRCA mutation.

Clovis Withdraws Rubraca Ovarian Cancer Indication Due To Survival Imbalance

Third-line BRCA-mutated ovarian cancer indication is not a major loss for Rubraca, but Clovis also faces delay in filing to add first-line ovarian cancer therapy to product label.

Fresh EU Okay For Rubraca Boosts Clovis

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.

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