Regulatory Decision Summary for Opdivo

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

Nivolumab

Therapeutic area:

Antineoplastic Agents

Type of submission:

Supplemental New Drug Submission

Control number:

247045
What was the purpose of this submission?

 

The purpose of this submission is to obtain marketing authorization for Opdivo (nivolumab) for the adjuvant treatment of resected esophageal or gastroesophageal junction cancer in adults who had previous chemo-radiotherapy (CRT) and complete resection of the cancer.

After evaluation of the submitted data package, Health Canada authorized the following indication:

  • Adjuvant Treatment of Resected Esophageal or Gastroesophageal Junction (GEJ) Cancer Opdivo is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer in patients who have residual pathologic disease following prior neoadjuvant chemoradiotherapy (CRT).

 

Why was the decision issued?

 

Authorization was based on pivotal study CHECKMATE-577 (CA209577), which included 795 patients with completely resected esophageal or gastroesophageal cancer who had residual pathologic disease following tri-modality therapy (a combination of chemotherapy, radiation and surgery). As the risk of disease recurrence remains high in these patients, study CHECKMATE-577 evaluated the use of nivolumab in the early disease setting and showed that it can improve patient outcomes: 795 patients (aged 18 to 65 years) with stage II or stage IIII Esophageal cancer (EC) or gastroesophageal cancer (GEC) were randomized in a 2:1 ratio to either nivolumab (n = 532) (240 mg intravenous (IV) every 2 weeks (Q2W) for 16 weeks, followed by 480 mg IV every 4 weeks (Q4W)) or placebo (n = 262) and treated until disease recurrence, unacceptable toxicity or consent withdrawal with a maximum treatment duration of one year. The primary efficacy endpoint was disease-free survival (DFS), and the secondary efficacy endpoint overall survival (OS), tested in hierarchy. The study met its primary endpoint with improvement in the median DFS of 22.4 in the nivolumab group compared to 11 months in the placebo group. The key secondary endpoint of OS was not evaluated at the interim analysis as data was considered immature. There were no significant concerns from a biostatistical perspective. The safety profile of nivolumab in patients with resected esophageal/GEJ cancer following neoadjuvant chemoradiation was comparable to the known safety profile in other diseases, please see the product monograph for more details.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations