This site is intended for U.S. healthcare professionals.

Visit Pfizer Medical

Menu

Close

Sign InLog Out
ProductsOrderMaterialsCo-pay Cards & Patient Savings OffersRequest SamplesHospital ProductsVaccinesPatient AssistancePfizer Oncology TogetherPfizer RxPathwaysExplore ContentEventsMaterialsVideosContact
Search
Button

Menu

Close

HomeBRAF-mutant mCRC and MOABRAF-mutant mCRC and MOA

Example of description text sitting alongside header

Unmet need in BRAF-mutant mCRCPeer perspectives in BRAF-mutant mCRCMOALabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Efficacy​​​​​Efficacy

Example of description text sitting alongside header

Trial designSelect patient characteristicsOverall survivalOverall response rate/Duration of responseProgression-free survivalLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
SafetySafety

Example of description text sitting alongside header

Adverse reactionsLab abnormalitiesLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
DosingDosing

Example of description text sitting alongside header

Dosing & administrationDose reductionsLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
ResourcesResources

Example of description text sitting alongside header

Access & patient supportEventsMaterialsOncologist resourcesVideosLabelLinkLinkLinkLinkLabelLinkLinkLinkLink
Prescribing InformationMedication GuideIndicationPatient Site
BRAFTOVI + cetuximabThe first and only FDA-approved targeted therapy regimen for adults with previously treated mCRC with a BRAF V600E mutation, and not for use in patients with wild-type BRAF mCRC1-5Superior overall survival vs control1

(HR=0.60 [95% CI: 0.45-0.79], P=0.0003)

Median OS
8.4 MONTHS
(95% CI: 7.5-11.0)
BRAFTOVI® (encorafenib) + cetuximab (n=220)

vs

5.4 MONTHS (95% CI: 4.8-6.6) 
Control: FOLFIRI + cetuximab or irinotecan + cetuximab (n=221)

See trial design Loading See clinical trial results Loading

BEACON CRC was a Phase 3, global, randomized (1:1:1), active-controlled, open-label, multicenter, clinical trial in 665 adults with BRAF V600E–mutant mCRC with disease progression after 1 or 2 prior regimens. Patients received BRAFTOVI + cetuximab (n=220), BRAFTOVI + cetuximab + binimetinib (n=224), or control of irinotecan or FOLFIRI, both with cetuximab (n=221). OS was the major efficacy outcome measure. ORR, PFS, and DoR were additional efficacy outcome measures (all per BICR).1,6 Please see Trial Design for additional data.

Peer perspectives in BRAF-mutant mCRC

Watch a leading oncologist from Washington, DC discuss the poor prognosis of BRAF V600E-mutant mCRC 

Watch video Loading
Patients with BRAF-mutant mCRC have a poor prognosis  Learn more Loading Targeted regimen combining oral and infusion therapy See dosing information Loading Learn about access and support resources for eligible patients Learn more Loading
Encorafenib (BRAFTOVI®) + cetuximab is the only FDA-approved targeted therapy regimen for adults with previously treated mCRC with a BRAF V600E mutation and is a recommended therapy option (Category 2A) within the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1-5,7,8* ReferencesCategory 2A: Based on lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.7,8

BICR, blinded independent central review; CI, confidence interval; DoR, duration of response; FOLFIRI, folinic acid + fluorouracil + irinotecan; HR, hazard ratio; mCRC, metastatic colorectal  cancer; NCCN, National Comprehensive Cancer Network® (NCCN®); ORR, overall response rate; OS, overall survival; PFS, progression-free survival; 2L+, second-line or later.
References:BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2022.Erbitux® (cetuximab) Prescribing Information. Eli Lilly and Company; 2021.Center for Drug Evaluation and Research. Approved Drugs - Hematology/Oncology (Cancer) Approvals & Safety Notifications. Internet Archive Wayback Machine. Accessed March 6, 2020. http://wayback.archive-it.org/7993/20170111064250/http:/www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htmCenter for Drug Evaluation and Research. Approved Drugs - Hematology/Oncology (Cancer) Approvals & Safety Notifications. US Food and Drug Administration. Accessed March 6, 2020. https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety notificationsCenter for Drug Evaluation and Research. Oncology (Cancer) / Hematologic Malignancies Approval Notifications. US Food and Drug Administration. Accessed August 5, 2021. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notificationsKopetz S, Grothey A, Yaeger R, et al. N Engl J Med. 2019;381(17):1632-1643.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Colon Cancer V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed February 25, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Rectal Cancer V.1.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed February 25, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2022 Pfizer Inc. All rights reserved.

PP-BRA-USA-0232 October 2022
You are now leaving Pfizer

You are now leaving a Pfizer operated website. Links to all outside sites are provided as a resource to our visitors. Pfizer accepts no responsibility for the content of sites that are not owned and operated by Pfizer. 


PP-BRA-USA-0232
INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
 

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.​​​​​​​

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS


New Primary Malignancies, cutaneous and non-cutaneous, can occur with BRAFTOVI. In the BEACON CRC trial, cutaneous squamous cell carcinoma (cuSCC), including keratoacanthoma (KA), occurred in 1.4% of patients with CRC, and a new primary melanoma occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab. Perform dermatologic evaluations prior to initiating treatment, every 2 months during treatment, and for up to 6 months following discontinuation of treatment. Manage suspicious skin lesions with excision and dermatopathologic evaluation. Dose modification is not recommended for new primary cutaneous malignancies. Based on its mechanism of action, BRAFTOVI may promote malignancies associated with activation of RAS through mutation or other mechanisms. Monitor patients receiving BRAFTOVI for signs and symptoms of non-cutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.

Tumor Promotion in BRAF Wild-Type Tumors: In vitro experiments have demonstrated paradoxical activation of MAP-kinase signaling and increased cell proliferation in BRAF wild-type cells exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K mutation using an FDA-approved test prior to initiating BRAFTOVI. 

Hemorrhage: In BEACON CRC, hemorrhage occurred in 19% of patients receiving BRAFTOVI in combination with cetuximab; Grade 3 or higher hemorrhage occurred in 1.9% of patients, including fatal gastrointestinal hemorrhage in 0.5% of patients. The most frequent hemorrhagic events were epistaxis (6.9%), hematochezia (2.3%), and rectal hemorrhage (2.3%). Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Uveitis: Uveitis, including iritis and iridocyclitis, has been reported in patients treated with BRAFTOVI. Assess for visual symptoms at each visit. Perform an ophthalmological evaluation at regular intervals and for new or worsening visual disturbances, and to follow new or persistent ophthalmologic findings. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

QT Prolongation: BRAFTOVI is associated with dose-dependent QTc interval prolongation in some patients. Monitor patients who already have or who are at significant risk of developing QTc prolongation, including patients with known long QT syndromes, clinically significant bradyarrhythmias, severe or uncontrolled heart failure and those taking other medicinal products associated with QT prolongation. Correct hypokalemia and hypomagnesemia prior to and during BRAFTOVI administration. Withhold, reduce dose, or permanently discontinue for QTc >500 ms.

Embryo-Fetal Toxicity: BRAFTOVI can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose. Advise females to contact their healthcare provider of a known or suspected pregnancy.

Lactation: Advise women not to breastfeed during treatment with BRAFTOVI and for 2 weeks after the final dose.

Infertility: Advise males of reproductive potential that BRAFTOVI may impair fertility.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab. Refer to the prescribing information for cetuximab for additional risk information.

ADVERSE REACTIONS

The most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: fatigue (51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%), dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%), decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash (26% vs 26%). Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab was pancreatitis.

The most common laboratory abnormalities (≥20%, all grades) in the BRAFTOVI with cetuximab arm compared to irinotecan with cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs 48%) and lymphopenia (24% vs 35%).

DRUG INTERACTIONS

Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors (including grapefruit juice) or CYP3A4 inducers and use caution with sensitive CYP3A4 substrates. Avoid coadministration of BRAFTOVI with hormonal contraceptives.

Modify BRAFTOVI dose if coadministration with a strong or moderate CYP3A4 inhibitor cannot be avoided.

Avoid coadministration of BRAFTOVI with drugs known to prolong QT/QTc interval.

Dose reductions of drugs that are substrates of OATP1B1, OATP1B3, or BCRP may be required when used concomitantly with BRAFTOVI.

Refer to the cetuximab prescribing information for recommended dosing and safety information.

Please see full Prescribing Information including Medication Guide for BRAFTOVI.

INDICATION AND USAGE BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.

Limitations of Use: BRAFTOVI is not indicated for treatment of patients with wild-type BRAF CRC.​​​​​