Regulatory Decision Summary for Keytruda

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:


Medicinal Ingredient(s):


Control Number:


Brand/Product Name:


Therapeutic Area:

Antineoplastic Agents

Type of Submission:

Supplement to a New Drug Submission

Decision Issued:

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

What was the purpose of this submission?

This Supplemental New Drug submission (SNDS) was submitted to seek an expanded indication for Keytruda for the adjuvant treatment of fully resected Stage III melanoma to include pediatrics (12 years and older).

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

Keytruda is indicated for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB, IIC or III melanoma following complete resection.

Why was the decision issued?

Keytruda is currently authorised for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection as well as the adjuvant treatment of adult patients with Stage III melanoma with lymph node involvement who have undergone complete resection.

The expansion of the current indication to include stage III melanoma in the pediatric population, 12 years of age or older, was based on an extrapolation of the results observed in adult patients with stage IIB, IIC and III, to pediatric patients with the same disease. Extrapolation was justified based on a rationale outlining the similarities of the adult and pediatric with Stage III melanoma in terms of, for example, disease biology, risk and prognosis, mechanism of action of pembrolizumab and exposure to pembrolizumab. This approach is guided by the International Council for Harmonisation (ICH) for expanding the use of therapeutic agents to the pediatric population. The observed safety of pembrolizumab, administered at the recommended dosage regimen of 2 mg/kg once every 3 weeks, in pediatric patients also informed key components of this decision. Furthermore, there is mounting evidence of efficacy of Pembrolizumab in pediatric melanoma and other pediatric malignancies. Based on the assessment of the totality of evidence, it was recommended that the authorization of pembrolizumab include pediatric patients 12 years of age and older with stage III melanoma.

The recommended dose regimen of Keytruda for adult patients is 200 mg administered as an intravenous infusion every 3 weeks or 400 mg administered as an intravenous infusion every 6 weeks. The recommended dose for pediatric patients (12 years and older) is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks. For both adult and pediatric patients, it is recommend that treatment continue until disease progression, unacceptable toxicity, or for up to 17 doses whichever is longer in patients without disease recurrence.

Overall, the benefit/risk profile of the pembrolizumab is favorable, and based on the totality of the evidence presented, Health Canada has granted authorization for Keytruda in the treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC or III melanoma following complete resection.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Keytruda, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.

Date of Decision:



Merck Canada Inc.

Drug Identification Number(s) Issued:


Prescription Status:

Schedule D drug

Date Filed: