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It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors

 
• By Brenda Sandburg

PARP inhibitors appear to be getting the same kind of scrutiny that US FDA has given to P13K inhibitors. AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.

Ovarian cancer
Sponsors withdraw certain indications for ovarian cancer drugs based on overall survival data • Source: Shutterstock

The US Food and Drug Administration approved three PARP inhibitors for third- and fourth-line ovarian cancer indications based on the results of single-arm studies showing improvement in objective response rate or progression-free survival. But subsequent randomized trials indicate that they may have a detrimental effect on overall survival, leading the sponsors to withdraw the indications.

The three poly (ADP-ribose) polymerase (PARP) inhibitors are Clovis Oncology, Inc.’s Rubraca (rucaparib), AstraZeneca PLC’s Lynparza (olaparib), and GlaxoSmithKline Pharmaceuticals Ltd.’s Zejula (niraparib).

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