FDA Approves Bristol Myers Squibb's Opdivo for NSCLC

Bristol Myers Squibb’s Opdivo (nivolumab) has gained approval from the US Food and Drug Administration (FDA) as part of a perioperative treatment for adults with non-small cell lung cancer (NSCLC). This anti-PD-1 therapy is now sanctioned for use in combination with platinum-doublet chemotherapy before surgery, and as a standalone treatment after surgery.

The treatment regimen targets patients with resectable NSCLC who do not possess epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. Each year, lung cancer is diagnosed in over 200,000 individuals in the United States, and NSCLC forms up to 85% of these cases.

Opdivo aims to harness the body's immune system to restore its anti-tumor response. It was previously approved by the FDA as a neoadjuvant treatment in combination with platinum-doublet chemotherapy for adults with resectable NSCLC. The recent FDA approval was bolstered by favorable outcomes from the phase 3 CheckMate-77T trial. This trial demonstrated that the Opdivo regimen enhances event-free survival rates compared to chemotherapy combined with a placebo.

In the CheckMate-77T trial, patients treated with Opdivo showed a 42% reduction in the risk of disease recurrence, progression, or death compared to those receiving chemotherapy plus placebo, with a median follow-up of 25.4 months. Furthermore, 25% of patients in the Opdivo group achieved a pathologic response, compared to just 4.7% in the control group.

Wendy Short Bartie, senior vice president of US oncology and hematology at Bristol Myers Squibb (BMS), remarked on the approval, stating, “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.”

This recent approval follows closely behind the announcement of positive ten-year follow-up data from a late-stage study evaluating Opdivo in combination with Yervoy (ipilimumab) for patients with previously untreated advanced or metastatic melanoma. Additionally, the company has reported results from a phase 3 study of Opdivo plus Yervoy as an initial treatment for unresectable hepatocellular carcinoma.