STAT+: FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’
Merck (MRK) 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 Food and Drug Administration.
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. An approval would further expand the market for one of the world’s hottest drugs, which is already used to combat numerous cancers. Last year, Keytruda generated $14.4 billion in sales, a 30% increase, and 30% of Merck revenue.
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