FDA Grants Priority Review to Treatment for Resected Esophageal or Gastroesophageal Junction Cancer
FDA grant priority review to a supplemental biologics license application for nivolumab (Opdivo) for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction cancer.
The FDA has granted priority review to a supplemental biologics license application for nivolumab (Opdivo) for use as an adjuvant treatment for patients with resected esophageal or gastroesophageal junction (GEJ) cancer following neoadjuvant chemoradiation treatment.1 The application was based on data from the phase 3 CheckMate-577 trial (NCT02743494), which demonstrated that nivolumab resulted in a statistically significant and clinically meaningful improvement in disease-free survival (DFS) compared with placebo in patients with resected esophageal or GEJ cancer after neoadjuvant chemoradiation.2
The median DFS with adjuvant nivolumab was 22.4 months (95% CI, 16.6-34.0) versus 11.0 months (95% CI, 8.3-14.3) with placebo (HR, 0.69; 95% CI, 0.56-0.86; P = .0003); this translated into a 31% reduction in the risk of recurrence or death in this population. Notably, this benefit was observed across all prespecified subgroups analyzed, including age, sex, race, ECOG performance status, disease stage at initial diagnosis, tumor location, histology, pathologic lymph node status, and PD-L1 expression.
Under the Prescription Drug User Fee Act, the FDA must make a decision by May 20, 2021.
“The FDA’s acceptance of our application marks important progress toward our goal of advancing treatment options for patients with esophageal or gastroesophageal junction cancer, in this case in early-stage disease,” Ian M Waxman, MD, development lead, gastrointestinal cancers at Bristol Myers Squibb, stated in a press release. “We look forward to working with the FDA to potentially bring [nivolumab] to these patients, who face a critical unmet need and remain at high risk for disease recurrence.”