FDA Approves BMS’ Opdivo for Perioperative Treatment of Resectable Non-Small Cell Lung Cancer

FDA Approval:
The FDA has approved Bristol Myers Squibb's (BMS) Opdivo (nivolumab) for the perioperative treatment of adult patients with resectable non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) rearrangements.

Treatment Regimen:
The approved regimen includes neoadjuvant treatment with Opdivo in combination with platinum-doublet chemotherapy, followed by surgery, and then adjuvant single-agent Opdivo.

Clinical Trial:
The approval is based on the results of the CheckMate-77T trial, which demonstrated that the combination significantly improved event-free survival (EFS) and pathologic complete response (pCR) compared to chemotherapy alone.

Efficacy:
The trial showed a 42% reduction in the risk of disease recurrence, progression, or death with Opdivo, with 25% of patients achieving pCR and a median follow-up of 25.4 months.

Safety:
The safety profile was comparable to that seen in other clinical trials of nivolumab plus chemotherapy, with no new safety signals observed.

Impact:
This approval expands the role of Opdivo-based treatments in NSCLC and addresses the need for options that can be administered before and after surgery to reduce the risk of cancer returning and improve the chance of successful surgical treatment.