Bristol Myers Squibb’s Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA) as part of a perioperative treatment regimen for adults with non-small cell lung cancer (NSCLC).
The PD-1 inhibitor has been authorised for use alongside platinum-doublet chemotherapy as a neoadjuvant treatment before surgery and as an adjuvant monotherapy after surgery.
Patients eligible for the regimen will have resectable NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
More than 200,000 people are diagnosed with lung cancer in the US every year, with NSCLC accounting for up to 85% of cases.
Opdivo, which is designed to use the body’s own immune system to help restore anti-tumour immune response, was previously approved by the FDA in combination with platinum-doublet chemotherapy for adults with resectable NSCLC in the neoadjuvant setting.
The regulator’s latest decision was supported by positive results from the phase 3 CheckMate-77T trial, in which the Opdivo regimen was shown to improve event-free survival compared to chemotherapy plus placebo.
The risk of disease recurrence, progression or death was reduced by 42% in patients randomised to the Opdivo arm, compared to chemotherapy plus placebo, with a median follow-up of 25.4 months.
Additionally, 25% of patients in the Opdivo cohort achieved pathologic response, while 4.7% of those in the comparator arm achieved pathologic response in the intent-to-treat population.
Commenting on the authorisation, Wendy Short Bartie, senior vice president of US oncology and haematology at BMS, said: “This milestone expands the role of Opdivo-based treatments and builds upon the foundation set by the FDA approval of neoadjuvant-only Opdivo plus chemotherapy in resectable NSCLC based on the CheckMate-816 trial.”
The latest approval comes less than three weeks after BMS announced positive ten-year follow-up data from a late-stage study evaluating Opdivo in combination with its human monoclonal antibody Yervoy (ipilimumab) in patients with previously untreated advanced or metastatic melanoma.
The company also recently shared results from a phase 3 study of Opdivo plus Yervoy as a first-line treatment for unresectable hepatocellular carcinoma.