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.

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.