FDA Approves Opdivo (Nivolumab) as First Immunotherapy for Adjuvant Treatment of Resected Esophageal or GEJ Cancer

Esophageal cancerIt is a malignant tumor occurring in the esophageal epithelial tissue.China is a high-incidence region for esophageal cancer, with smoking and alcohol consumption being common etiological factors, among which esophageal squamous cellCancerMost common.

May 20, 2021, U.S. Food and Drug Administration（FDA）Approvednivolumab(Opdivo, Bristol-Myers Squibb Company)For completely resected esophageal or gastroesophageal junction cancer（GEJ）Patients with residual pathologic disease who received neoadjuvant chemoradiotherapy.

Opdivo is the first immunotherapy approved for the adjuvant treatment of this patient population.

This approval is based on the trial namedCHECKMATE-577results of the randomized, double-blind, placebo-controlled Phase 3 trial, which included 794 patients with esophageal or gastroesophageal junction (GEJ) cancer who underwent complete resection.

The trial results show that,Compared with the placebo group, patients treated with Opdivo demonstrated a statistically significant improvement in disease-free survival (DFS).. The median DFS in the Opdivo group was 22.4 months.（95% CI：16.6，34.0）, this value was 11 months in the control group.（95% CI：8.3，14.3）。DFS benefit was observed regardless of tumor PD-L1 expression and histology.

For resected esophageal cancer or GEJ cancer, the recommended dose of nivolumab is 240 mg every 2 weeks or 480 mg every 4 weeks, for a total treatment duration of 1 year.Both doses were administered as a 30-minute intravenous infusion.

Most Common Adverse Reactions in Patients Receiving Nivolumab(Incidence ≥ 20%)are fatigue, rash, musculoskeletal pain, pruritus, diarrhea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, fever, headache, abdominal pain, and vomiting.

Senior Vice President, US Cardiovascular, Immunology and Oncology, Bristol-Myers SquibbAdam LenkowskyMr. [Name] said, "Today's approval represents a significant step forward for patients and marks meaningful progress in our efforts to develop immunotherapy options for patients with early-stage disease."

Reference link: FDA approves nivolumab for resected esophageal or GEJ cancer | FDA