FDA Approves Encorafenib Plus Cetuximab Therapy For Metastatic Colorectal Cancer Treatment


The FDA has approved encorafenib in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation after prior therapy.

The FDA has approved encorafenib (Braftovi, Pfizer, Inc) in combination with cetuximab (Erbitux, Eli Lilly) for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAFV600E mutation, as detected by an FDA-approved test, after prior therapy.

Encorafenib plus cetuximab is the first-and-only FDA-approved targeted regimen specifically for adults with previously treated metastatic CRC with a BRAFV600E mutation. Additionally, the FDA granted Priority Review and Breakthrough Therapy designation to the combination therapy.

The approval is based on results from the BEACON CRC trial, the only phase 3 trial to specifically study patients with previously treated metastatic CRC with a BRAFV600E mutation. Based on results from the BEACON CRC trial, encorafenib plus cetuximab showed a median overall survival (OS) of 8.4 months compared with 5.4 months for control (irinotecan with cetuximab). Additionally, encorafenib plus cetuximab showed an improved objective response rate of 20% compared with 2% for control, and median progression-free survival was 4.2 months with encorafenib plus cetuximab versus 1.5 months with control.

“BRAF mutations are estimated to occur in up to 15% of people with metastatic colorectal cancer and represent a poor prognosis for these patients,” said Scott Kopetz, MD, PhD, FACP, associate professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center. “As the first-and-only targeted regimen for people with BRAFV600E-mutant metastatic CRC who have received prior therapy, encorafenib plus cetuximab is a much-needed new treatment option for these patients.”

The most common adverse reactions seen in patients treated with encorafenib plus cetuximab were fatigue, nausea, diarrhea, dermatitis acneiform, abdominal pain, decreased appetite, arthralgia, and rash.


United States FDA Approves Braftovi (Encorafenib) in Combination with Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer (CRC) After Prior Therapy [news release]. Pfizer website. Published April 8, 2020. https://www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_braftovi_encorafenib_in_combination_with_cetuximab_for_the_treatment_of_brafv600e_mutant_metastatic_colorectal_cancer_crc_after_prior_therapy. Accessed April 9, 2020.

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