Regulatory approval
Published by the Food and Drug Administration.
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 is written in the approval document as:
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.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | BRAF p.V600E | Melanoma | Atezolizumab, Cobimetinib, Vemurafenib | |
| Sensitivity (+) | BRAF p.V600K | Melanoma | Atezolizumab, Cobimetinib, Vemurafenib |