Bristol Myers Squibb Co. on Monday said the U.S. Food and Drug Administration granted priority review to its application seeking expanded approval of its blockbuster cancer drug Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer.
The New York biopharmaceutical company said the application is based on a Phase 3 study in which Opdivo plus chemotherapy showed a statistically significant and clinically meaningful improvement in pathologic complete response and event-free survival versus chemotherapy alone when given before surgery.
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. Bristol Myers said the agency set a target action date of July 13 for its application
Opdivo, which harnesses the body's own immune system to fight cancer, is currently approved in more than 65 countries across multiple cancers.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.