By Colin Kellaher
Bristol-Myers Squibb Co. (BMY) said Wednesday the U.S. Food and Drug Administration accepted for priority review its supplemental biologics license application for Opdivo in combination with Yervoy for the treatment of a form of lung cancer.
The New York biopharmaceutical company said the filing covers the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
Non-small cell lung cancer is one of the most common types of lung cancer, accounting for up to 85% of diagnoses.
Bristol-Myers said the FDA set a target action date of May 15 for the application.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months.
Write to Colin Kellaher at email@example.com