Therapeutic Response Statement (Sensitivity)

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

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

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

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor.

Citation

Bristol-Myers Squibb Canada. Opdivo (nivolumab) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00076152.PDF. Revised June 2024. Accessed June 2025.