FDA Gives Priority Review to Regeneron’s Nonsmall-Cell Lung Cancer Drug
The FDA has granted Regeneron’s and Sanofi’s priority review request for their monoclonal antibody Libtayo (cemiplimab-rwlc) as a first-line treatment for patients with metastatic nonsmall-cell lung cancer.
The agency’s decision to give the monoclonal antibody priority review was supported by positive results from a phase 3 study that compared Libtayo vs. platinum-based chemotherapy, the standard of care.
The FDA has set a target action date for Feb. 28, 2021. The European Medicines Agency is also reviewing the drug for the same indication and is expected to decide by the second quarter of 2021.