The U.S. FDA has granted breakthrough therapy designation and priority review to Merck’s immunotherapy cancer drug, Keytruda, for first-line treatment of patients with the most common form of lung cancer.
In October, Keytruda was approved for use as a second-line treatment in patients with non-small-cell lung cancer (NSCLC) whose tumors contain a certain level of the protein PD-L1, and whose disease continued to worsen after chemotherapy. Merck is now seeking approval for Keytruda as a stand-alone treatment for patients whose tumors express PD-L1, based on data from a pivotal phase 3 Keynote-024 study released in June.
If approved, Keytruda will steal market share from Bristol-Myers Squibb's rival drug Opdivo, which recently failed to hit its trial goals in previously untreated NSCLC patients.
The target action date for Merck's application is Dec. 24, 2016.
Read the press release