The reach of Bristol-Myers Squibb’s Opdivo (nivolumab) is steadily increasing in the US as regulators green-light its use to treat non-squamous non-small cell lung cancer.
The US Food and Drug Administration has approved the injection for use in patients with metastatic NSCLC with progression on or after platinum-based chemotherapy, or other targeted therapy in those with EGFR mutation or ALK translocation.
Approval came on the back of an interim analysis of data from the Phase III CheckMate-057, which showed that Opdivo demonstrated superior overall survival in the target patient population compared to chemotherapy, with a 27% reduction in the risk of death. Also, median overall survival was 12.2 months versus 9.4 months, respectively.
Squamous and non-squamous NSCLC together represent approximately 85%-90% of cases of lung cancer - a notoriously difficult to treat disease with a high mortality rate - and Opdivo is now the only PD-1 inhibitor approved in both types regardless of PD-L1 expression.
Murdo Gordon, senior vice president and head of Worldwide Markets, Bristol-Myers Squibb, said it is “encouraging to know that Opdivo will be available to significantly more patients with metastatic NSCLC, helping to improve treatment outcomes for patients who have been previously treated”.
In the US, the PD-1 checkpoint inhibitor was first approved in December last year 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, a decision for which is expected by the end of November.
If successful in all its proposed indications, analysts believe the drug could pull in peak annual sales of as much as $7 billion.