Merck's Keytruda survives FDA scrutiny in bladder cancer, but ends up with a smaller label

Merck's Keytruda survives FDA scrutiny in bladder cancer, but ends up with a smaller label

Source: 
Fierce Pharma
snippet: 

After a positive opinion from a panel of independent FDA advisers, Merck has won a full FDA go-ahead for Keytruda in newly diagnosed advanced bladder cancer. But there’s a catch. The FDA has converted Keytruda’s conditional nod in newly diagnosed advanced bladder cancer into a full approval, Merck said Tuesday. But the new label only covers patients who are ineligible for any platinum-containing chemotherapy.