On 3 October 2024, BMS announced that the FDA has approved Opdivo® (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by single-agent Opdivo® as adjuvant treatment after surgery.
The approval is based on results from the CheckMate-77T trial, the company’s second positive Phase 3 randomized trial with an immunotherapy-based combination for the treatment of resectable NSCLC.
This follows the February 2024 FDA acceptance of BMS’ sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB NSCLC and Opdivo®’s listing earlier this year on Australia’s PBS for resectable NSCLC.