FDA accepts Merck application for lung cancer combo therapy

Merck & Co on Tuesday said the FDA agreed to a speedy review of its application to combine its immunotherapy drug Keytruda with chemotherapy as an initial treatment for advanced lung cancer, potentially giving it a major leg up in the competition for the largest cancer market.

 

Merck said the U.S. Food and Drug Administration would decide by May 10 whether to approve the Keytruda combination therapy, sending the drugmaker’s shares more than 3 percent higher.

 

“This comes as an important surprise because if FDA approves the application, Merck would suddenly be catapulted ahead of all other (immunotherapy) competitors who are also pursuing competing combination regimens of their own,” Bernstein analyst Tim Anderson said in a research note, mentioning Roche, Bristol-Myers Squibb and AstraZeneca.