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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 Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors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 AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.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.

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Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
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EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

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HRA To Revisit Simplified Consent Provisions Under New UK Clinical Trials Law

 
• By Vibha Sharma

Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.