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Braftovi®plus cetuximab is the first U.S. Food and Drug Administration (FDA)-approved targeted treatment regimen for adults with previously treated metastatic CRC with a BRAFV600E mutation

On April 8, the FDA approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adults with BRAFV600E-mutant metastatic colorectal cancer (CRC) who have received prior therapy. This type of mutation-driven CRC is typically associated with a poor prognosis. Before the approval of Braftovi plus cetuximab, there were no targeted treatment regimens specifically approved for these patients.

Up to 15%​​​​​​​​​​​​​​​​​​

BRAF mutations are estimated to occur in up to 15% of people with metastatic CRC and represent a poor prognosis for these patients.1,2,3,4,5,6

2x risk

The BRAFV600E mutation is the most common BRAF mutation. The risk of mortality in CRC patients with the BRAFV600E mutation is more than two times higher than for those with wild-type BRAF.1,2 

Given the high unmet need, Pfizer was committed to bringing this critical treatment option to adults with previously treated BRAFV600E-mutant metastatic CRC, despite the widespread COVID-19 pandemic that was surging across the nation. The approval happened amid many stay-at-home restrictions, making this Pfizer’s first-ever virtual product launch in the U.S. Challenges aside, the team quickly pivoted in a five-week timeframe to ensure patients and health care providers were aware of this much-needed regimen.

As the first regulatory approval in the U.S. following Pfizer’s acquisition of Array BioPharma Inc., the Company is proud to bring this regimen to market without delay. It is a testament to our commitment to developing targeted medicines for difficult-to-treat, mutation-driven cancers.

Looking to 2021 and beyond, Pfizer remains steadfast in its commitment to helping certain patients with BRAF-mutant metastatic CRC and is excited to continue investigating this treatment regimen. Pfizer’s purpose remains unchanged – Breakthroughs that change patients’ lives. Looking ahead, Pfizer hopes to positively impact the lives of more people battling this devastating type of cancer.


1Corcoran, R. B., Ebi, H., Turke, A. B., Coffee, et al. (2012). EGFR-mediated re-activation of MAPK signaling contributes to insensitivity of BRAF mutant colorectal cancers to RAF inhibition with vemurafenib. Cancer discovery, 2(3), 227–235. doi:10.1158/2159-8290.CD-11-0341
2Sorbye, H., Dragomir, A., Sundström, M., et al. (2015). High BRAF Mutation Frequency and Marked Survival Differences in Subgroups According to KRAS/BRAF Mutation Status and Tumor Tissue Availability in a Prospective Population-Based Metastatic Colorectal Cancer Cohort. PloS one, 10(6), e0131046. doi:10.1371/journal.pone.0131046

3Saridaki, Z., Tzardi, M., Sfakianaki, M., et al. (2013). BRAFV600E Mutation Analysis in Patients with Metastatic Colorectal Cancer (mCRC) in Daily Clinical Practice: Correlations with Clinical Characteristics, and Its Impact on Patients’ Outcome. PLoS ONE,8(12). doi:10.1371/journal.pone.0084604

4Loupakis, F., Ruzzo, A., Cremolini, C., et al. (2009). KRAS codon 61, 146 and BRAF mutations predict resistance to cetuximab plus irinotecan in KRAS codon 12 and 13 wild-type metastatic colorectal cancer. British journal of cancer, 101(4), 715–721. doi:10.1038/sj.bjc.6605177

5Safaee Ardekani, G., Jafarnejad, S. M., Tan, L., et al. (2012). The prognostic value of BRAF mutation in colorectal cancer and melanoma: a systematic review and meta-analysis. PloS one, 7(10), e47054. doi:10.1371/journal.pone.0047054

6Vecchione, L., Gambino, V., Raaijmakers, J., et al. (2016). A Vulnerability of a Subset of Colon Cancers with Potential Clinical Utility. Cell,165(2), 317-330. doi:10.1016/j.cell.2016.02.059

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