Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that BRAF p.V600K status confers therapeutic sensitivity to Atezolizumab, Cobimetinib, Vemurafenib in patients with Melanoma.

The U.S. Food and Drug Administration granted approval to atezolizumab in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

This statement is based on a regulatory approval from the Food and Drug Administration:

TECENTRIQ is a programmed death-ligand 1 (PD-L1) blocking antibody indicated in combination with cobimetinib and vemurafenib for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma.

Citation

Genentech, Inc. Tecentriq (atezolizumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761034s053lbl.pdf. Revised April 2024. Accessed October 30, 2024.