Posted by Michael Wonder on 06 Feb 2021
FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’
5 February 2021 - Merck may have readily turned its Keytruda cancer drug into a medical and financial juggernaut, but its bid to win regulatory approval for at least one additional use may not come so easily, judging by documents from the FDA.
The drug maker wants to sell the medicine to combat high risk, early stage triple negative breast cancer along with chemotherapy before surgery, and then by itself after surgery.
