Shares in Bristol-Myers Squibb were given a nudge after US regulators accepted an application to expand the use of its immunotherapy Opdivo in lung cancer.
The firm has filed a supplemental Biologics License Application seeking permission to market Opdivo (nivolumab) for previously treated patients with non-squamous non-small cell lung cancer (NSCLC), adding to its approved indication in squamous NSCLC.
The FDA has also granted a priority review and breakthrough status for this indication, underscoring the need for new treatments for this patient population, “where currently a significant unmet medical need remains,” BMS notes.
The projected FDA action date on the sBLA is January 2, 2016.
In the US, the PD-1 checkpoint inhibitor was first approved in December as a second-line treatment for advanced melanoma, followed by a green light in March in the squamous NSCLC setting. BMS has also filed Opdivo as a first-line therapy for melanoma.
If successful in all its proposed indications, analysts believe the drug could pull in peak annual sales of as much as $7 billion.