It’s The Overall Survival, Sponsors! Ovarian Cancer Indications Withdrawn For Three PARP Inhibitors
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 AstraZeneca’s Lynparza, GSK’s Zejula, and Clovis’ Rubraca have indications voluntarily withdrawn after ‘potential detrimental effect’ on overall survival seen in randomized clinical trials.
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The second week of first-quarter earnings featured AbbVie’s announcement and a harsh stock price reaction. There were also far-reaching implications behind the results.
Keeping Track: Accelerated Approval Wins (Padcev+Keytruda) And Losses (Imbruvica To Shed MCL, MZL Claims)
The latest drug development news and highlights from the Pink Sheet's US FDA Perfomance Tracker.
The first BCMA-targeting agent to gain approval in myeloma never became the blockbuster for which GSK had hoped, but Blenrep appears to have set a new standard for speed of voluntary withdrawal of an accelerated approval drug after a confirmatory trial failure.