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Clovis Withdraws Rubraca’s Original Ovarian Cancer Indication Shows FDA Emphasis On Survival Data

 
• By Bridget Silverman

Clovis’ argument that an overall survival advantage seen for the chemotherapy control arm in the ARIEL4 trial is an artifact of the crossover design does not keep third-line and later ovarian cancer use on label; sNDA for first-line maintenance delayed.

'Withdrawal' hand written note laying on pile of folders and documents

Clovis Oncology highlighted the US FDA’s “increasing emphasis on overall survival (OS) in oncology trials” as a driving force behind the company’s voluntary withdrawal of one of the indications for the PARP inhibitor Rubraca (rucaparib) effective 10 June 2022.

The withdrawn claim, for treatment of ovarian and related cancers with deleterious BRCA mutations after two or more lines of...

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EMA Explores Supporting Drug Development For High Unmet Need Disorder Scleroderma

 
• By Neena Brizmohun

While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.

First Among Equals: US FDA CBER Director Prasad Gains Agency-Wide Authority

 
• By Bridget Silverman

As Chief Medical and Scientific Officer, Vinay Prasad will advise the FDA Commissioner on cross-cutting issues, provide strategic leadership and be a public face of the agency.

National Priority Voucher Gives US FDA Commissioner Tool For Radical Regulatory Surgery

 
• By Bridget Silverman

US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.