Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BRAF p.V600E status confers therapeutic sensitivity to Pembrolizumab in patients with Melanoma.

Health Canada approved pembrolizumab for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.

This statement is based on a regulatory approval from the Health Canada:

KEYTRUDA (pembrolizumab) is indicated for the treatment of adult patients with unresectable or metastatic melanoma and disease progression following ipilimumab therapy and, if BRAF V600 mutation positive, following a BRAF or MEK inhibitor.

Citation

Merck Canada Inc. Keytruda (pembrolizumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00080285.PDF. Published April 2025. Accessed June 2025.