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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The withdrawn claim, for treatment of ovarian and related cancers with deleterious BRCA mutations after two or more lines of lines of chemotherapy, was the inaugural indication for Rubraca, receiving an accelerated approval in 2016

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