ARTICLE | Product Development
Amid data showing decreased survival, ODAC to discuss Zejula
FDA panel to consider whether label for GSK’s PARP inhibitor should be modified in response to Phase III trial results
September 21, 2022 10:16 PM UTC
Updated on Sep 23, 2022 at 1:19 AM UTC
ODAC’s Nov. 22 meeting will consider whether the label for GSK’s Zejula should be modified in response to Phase III trial results in which patients who received the PARP inhibitor had shorter overall survival than those who received placebo.
The meeting of FDA’s Oncologic Drugs Advisory Committee is likely to consider whether increased progression-free survival (PFS) is sufficient to support continued marketing of the drug in the face of data showing decreased overall survival, and if the data are sufficiently robust to justify changing the indication. ...