In an incredibly speedy move, US regulators have approved Bristol-Myers Squibb’s PD-1 checkpoint inhibitor Opdivo (nivolumab) for lung cancer just one week after officially agreeing to review the application.
The US Food and Drug Administration handed down its decision well before the June 22 target date, expanding the immunotherapy’s use to include the treatment of squamous non-small cell lung cancer unresponsive to chemotherapy, adding to its original indication for advanced melanoma.
Approval came on the back of data showing that, on average, patients given Opdivo lived 3.2 months longer than those on docetaxel, while a separate trial arm showed an objective response rate (partial shrinkage or disappearance of the tumour) of 15% in patients taking the drug, of whom 59% had response durations of six months or longer.
Opdivo is now the first immunotherapy cleared for treatment of advanced squamous NSCLC. Its approval will “provide patients and healthcare providers knowledge of [its] survival advantage and will help guide patient care and future lung cancer trials,” said Richard Pazdur, director of the Office of Haematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
The news reportedly pushed the firm's stock to a 14-year high.
Merck & Co's rival immunotherapy Keytruda (pembrolizumab) - the first PD-1 checkpoint inhibitor to win US approval for melanoma - is scheduled to be filed for lung cancer during the first half of this year.