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