Amol Akhade, Senior Consultant at Fortis Hospitals Mumbai, shared on Х:
“EMA has raised concerned over Patina trial results.
Company has withdrawn the application at EMA for said indication.
EMA feels results may have been biased?”
Read more: Ibrance – withdrawal of application for variation to marketing authorisation
To which Yakup Ergün, Medical Oncologist at Bower Hospital, added:
“Frankly, Pfizer’s withdrawal of its application following the EMA’s concerns about efficacy and potential bias is surprising, given that the FDA approved the indication based on PATINA data.
Same trial, two different regulatory approaches.
Open-label trials, investigator assessment, censored data.
Yet I recall that the HR did not change much with independent review either.”
Other articles about EMA on OncoDaily.