Large Molecule

FDA to Rule on Merck Keytruda Combo by May

Jan 15, 2017

Merck & Co. announced that the U.S. FDA has accepted its application for a new Keytruda-plus-chemotherapy combo and granted the drugmaker priority review.

The FDA will decide by May 10 whether to approve the Keytruda combination therapy, giving Merck a huge leg-up on immunotherapy competitors, including Roche and BMS.

This first application for Keytruda as a combination treatment would include patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression level, opening up a much larger market for the medicine.

Read the press release