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HomeAbout BRAF V600EAbout BRAF V600E

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Unmet needTesting for BRAF mutant mCRCUnmet need in BRAF-mutant mCRCPeer perspectives in BRAF-mutant mCRCMOALabelLinkLinkLinkLinkLabelLinkLinkLinkLinkMOAMOA

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Mechanism of disease & mechanism of actionUnmet need in BRAF-mutant mCRCPeer perspectives in BRAF-mutant mCRCMOALabelLinkLinkLinkLinkLabelLinkLinkLinkLinkClinical Trial DataClinical Trial
Data

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BRAFTOVI + cetuximab + mFOLFOX6BRAFTOVI + cetuximab + FOLFIRISelect patient characteristicsOverall survivalOverall response rateOverall survivalDuration of responseLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkEfficacy​​​​​Efficacy

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Trial designProgression-free survivalSelect patient characteristicsOverall survivalOverall response rateOverall survivalDuration of responseLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkSafetySafety

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Adverse reactionsLaboratory abnormalitiesDose modificationsLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkDosingDosing

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Clinical Trial Data

BREAKWATER is a randomized, active-controlled, open-label, multicenter, phase 3 study that evaluated BRAFTOVI + cetuximab + mFOLFOX6 and BRAFTOVI + cetuximab + FOLFIRI in a separate cohort for first-line treatment of adult patients with BRAF V600E mutant mCRC.1

BRAFTOVI + cetuximab + mFOLFOX6BRAFTOVI + cetuximab + FOLFIRITrial Design
BREAKWATER: The only phase 3 trial to specifically study patients with previously untreated BRAF V600E mutant mCRC1,2

BREAKWATER is a randomized, active-controlled, open-label, multicenter, phase 3 study that evaluated the efficacy and safety of BRAFTOVI in combination with cetuximab and mFOLFOX6 vs control arm of chemotherapy* ± bevacizumab for first-line treatment of patients with BRAF V600E mutant mCRC.
  • The primary endpoints were PFS and ORR as assessed per BICR. Additional efficacy outcome measures included OS and DoR as assessed per BICR. OS and PFS were assessed in all randomized patients. ORR and DoR were assessed in the subset of the first 110 patients randomized in each arm1
  • Patients were initially randomized 1:1:1 and then 1:1 after discontinuation of enrollment of the BRAFTOVI + cetuximab arm (158 patients)1
    • BRAFTOVI 300 mg orally once daily in combination with cetuximab 500 mg/m2 IV infusion every 2 weeks and mFOLFOX6 every 2 weeks (BRAFTOVI + cetuximab + mFOLFOX6 arm)
    • mFOLFOX6 (every 2 weeks), or FOLFOXIRI (every 2 weeks), or CAPOX (every 3 weeks), each with or without bevacizumab (administered per prescribing instructions)
    • BRAFTOVI 300 mg orally once daily in combination with cetuximab 500 mg/m2 IV infusion every 2 weeks (BRAFTOVI + cetuximab arm)
  • Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, lost to follow-up, or death1
 mFOLFOX6: Oxaliplatin 85 mg/m2 IV infusion; leucovorin 400 mg/m2 IV infusion; 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every 2 weeks.1FOLFOXIRI: Irinotecan 165 mg/m2 IV infusion; oxaliplatin 85 mg/m2 IV infusion; leucovorin 400 mg/m2 IV infusion; 5-FU 2400 or 3200 mg/m2 continuous IV infusion over 46-48 hours (per local standard of care) every 2 weeks.1CAPOX: Oxaliplatin 130 mg/m2 IV infusion and capecitabine 1000 mg/m2 oral tablet BID Days 1-14 every 3 weeks. 1
Baseline demographics and disease characteristics were consistent across study arms2
Patient characteristics at baseline in BREAKWATER
  • Of the patients in the BRAFTOVI + cetuximab + mFOLFOX6 arm and the control arm, 59% were White, 37% were Asian, 0.4% were Multiracial, 0.2% were Black or African American, and 2.5% were not reported. Twelve percent (12%) were Hispanic or Latino, 81% were not Hispanic or Latino, and 7% were not reported1
The last assessment before the date of the first dose of trial intervention was used as baseline for the ECOG PS score (range, 0 to 5, with higher scores indicating greater disability) and biomarker variables. “Missing data” refers to data that were not collected but would have been available for collection. Percentages may not total 100 because of rounding. 2Data for the number of organs involved and the presence or absence of liver metastases were based on blinded independent central review. 2The local microsatellite instability status of microsatellite-stable, mismatch repair proficient includes low microsatellite instability. 2BID, twice daily; CAPOX, capecitabine and oxaliplatin; dMMR, mismatch repair deficient; ECOG, Eastern Cooperative Oncology Group; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; IV, intravenous; MSI-H, microsatellite instability-high; RAS, rat sarcoma virus GTPase. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437. PFS per BICR

BRAFTOVI + cetuximab + mFOLFOX6

Delivered additional 5-month median PFS benefit vs standard of care chemotherapy ± bevacizumab1*
Delivered additional 5-month median PFS benefit vs standard of care chemotherapy ± bevacizumab 1*

Primary endpoint: PFS per BICR
  • In the primary analysis of PFS (data cutoff, January 6, 2025), the number of events observed in each arm was 122/236 (52%) with BRAFTOVI + cetuximab + mFOLFOX6 and 132/243 (54%) with control. Of the 122 events in the BRAFTOVI + cetuximab + mFOLFOX6 group, 105 (45%) were progressive disease and 17 (7%) were deaths. Of the 132 events in the control group, 109 (45%) were progressive disease and 23 (10%) were deaths1,2
References Stratified log-rank test. Tested at 1-sided alpha level of 0.023.1

Exploratory progression-free survival analyses in prespecified subgroups2

This figure represents a prespecified analysis of PFS subgroups in the BREAKWATER trial. Small patient numbers can be a limitation of subgroup analyses. These subgroup analyses are exploratory and descriptive in nature, not powered to detect statistical differences, and not intended to demonstrate efficacy in particular subgroups. The confidence intervals are not adjusted for multiplicity and should not be interpreted as hypothesis tests.

 The stratification factors at randomization were the ECOG PS score (0 vs 1; on a 5-point scale, with higher scores indicating greater disability) and geographic region (United States or Canada vs Europe vs the rest of the world); the numbers of patients in the ECOG-based subgroups are based on the stratification factor. Data for the number of organs involved and the presence or absence of liver metastases were based on blinded independent central review.2CAPOX, capecitabine and oxaliplatin; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; HR, hazard ratio; mPFS, median progression-free survival. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437. ORR per BICR

BRAFTOVI + cetuximab + mFOLFOX6

Superior ORR vs control standard of care chemotherapy ± bevacizumab1*

Primary endpoint: ORR per BICR1†

 ORR and DoR were assessed in the subset of the first 110 patients randomized in each arm. Data cutoff, December 22, 2023.1,2Cochran-Mantel-Haenszel test; tested at a 1-sided alpha level of 0.001.1CAPOX, capecitabine and oxaliplatin; CI, confidence interval; CR, complete response; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; PR, partial response. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437. OS

BRAFTOVI + cetuximab + mFOLFOX6

Doubled median overall survival vs standard of care chemotherapy ± bevacizumab 1*

Key secondary endpoint: OS
  • In the primary analysis of OS (data cutoff, January 6, 2025), the number of events observed in each arm was 94/236 (40%) with BRAFTOVI + cetuximab + mFOLFOX6 and 148/243 (61%) with control1,2
Stratified log-rank test. Tested at 1-sided alpha level of 0.012.1

Exploratory overall survival analyses in prespecified subgroups2

This figure represents a prespecified analysis of OS subgroups in the BREAKWATER trial. Small patient numbers can be a limitation of subgroup analyses. These subgroup analyses are exploratory and descriptive in nature, not powered to detect statistical differences, and not intended to demonstrate efficacy in particular subgroups. The confidence intervals are not adjusted for multiplicity and should not be interpreted as hypothesis tests.

 The stratification factors at randomization were the ECOG PS score (0 vs 1; on a 5-point scale, with higher scores indicating greater disability) and geographic region (United States or Canada vs Europe vs the rest of the world); the numbers of patients in the ECOG-based subgroups are based on the stratification factor. Data for the number of organs involved and the presence or absence of liver metastases were based on blinded independent central review. 2CAPOX, capecitabine and oxaliplatin; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; HR, hazard ratio; mOS, median overall survival; NE, not estimable. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437.
Duration of response per BICR
DoR per BICR

BRAFTOVI + cetuximab + mFOLFOX6 vs control arm standard of care chemotherapy ± bevacizumab1*

Secondary endpoint (additional efficacy outcome measure): DoR per BICR1†

DoR was a descriptive analysis and was not powered to look at statistical difference.2

References ORR and DoR were assessed in the subset of the first 110 patients randomized in each arm. Data cutoff, December 22, 2023.1,2CAPOX, capecitabine and oxaliplatin; CI, confidence interval; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; NE, not estimable. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437.
Adverse reactions 1

Select safety profile

  • Use of BRAFTOVI is associated with the following WARNINGS and PRECAUTIONS: New Primary Malignancies, Tumor Promotion in BRAF Wild-Type Tumors, Cardiomyopathy, Hepatotoxicity, Hemorrhage, Uveitis, QT Prolongation, Embryo-Fetal Toxicity, and Risks Associated with Combination Treatment
Safety: ARs, Dose Modifications, & Lab Abnormalities
  • Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%)
  • Fatal intestinal obstruction occurred in 0.9% of patients, and fatal large intestinal perforation and gastrointestinal perforation occurred in 0.4% (each) of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6
  • The most common (≥25%) adverse reactions of BRAFTOVI when used in combination with cetuximab and mFOLFOX6 were peripheral neuropathy, nausea, fatigue, diarrhea, decreased appetite, rash, vomiting, hemorrhage, abdominal pain, arthralgia, pyrexia, and constipation
Adverse reactions occurring in ≥10% of patients receiving the BRAFTOVI regimen*
  • Other clinically important adverse reactions occurring in <10% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 were: Drug hypersensitivity, hyperkeratosis, and pancreatitis
References Grades per National Cancer Institute CTCAE v4.03. 1Represents multiple related terms. 1Represents a subset of the control arm (mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab). 1
Laboratory abnormalities1§

The most common Grade 3 or 4 laboratory abnormalities (≥10%) of BRAFTOVI when used in combination with cetuximab and mFOLFOX6 were increased lipase, decreased neutrophil count, decreased hemoglobin, decreased white blood cell count, and increased glucose.

Laboratory abnormalities occurring in ≥20% (all grades) of patients receiving BRAFTOVI + cetuximab + mFOLFOX6 in BREAKWATER

 References The denominator used to calculate the rate varied from 220 to 227 based on the number of patients with a baseline and at least one post-treatment value.1Grades per National Cancer Institute CTCAE v4.03. 1 Represents a subset of the control arm (mFOLFOX6 with or without bevacizumab or FOLFOXIRI with or without bevacizumab or CAPOX with or without bevacizumab).1
Dose modifications or permanent discontinuation of BRAFTOVI when used in combination with cetuximab + mFOLFOX61

Adverse reactions leading to dose interruptions, dose reductions, or permanent discontinuation of BRAFTOVI

Duration of exposure to BRAFTOVI when used in combination with cetuximab and mFOLFOX6

Among patients who received BRAFTOVI with cetuximab and mFOLFOX6 (N=232)1

 CAPOX, capecitabine and oxaliplatin; CTCAE, Common Terminology Criteria for Adverse Events; FOLFOXIRI, 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan; INR, international normalized ratio. Reference: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. AR, adverse reaction; BICR, blinded independent central review; BRAF, B-Raf proto-oncogene; DoR, duration of response; FOLFIRI, fluorouracil, leucovorin, and irinotecan; mCRC, metastatic colorectal cancer; mFOLFOX6, 5-fluorouracil, leucovorin, and oxaliplatin; ORR, objective response rate; OS, overall survival; PFS, progression-free survival. References: BRAFTOVI® (encorafenib) Prescribing Information. Array BioPharma, Inc.; February 2026. Elez E, Yoshino T, Shen L, et al. N Engl J Med. 2025;392(24):2425-2437. Clinical Trial Data Therapy Management Guide Download Loading Download Loading

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INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

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


IMPORTANT SAFETY INFORMATION

Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for recommended dosing and additional safety information.

WARNINGS AND PRECAUTIONS

New Primary Malignancies: New primary malignancies, cutaneous and noncutaneous, can occur. In the BREAKWATER trial, the following cutaneous malignancies occurred in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6: melanocytic nevus in 5.6%, skin papilloma in 3%, basal cell carcinoma in 1.3%, squamous cell carcinoma of skin in 0.9%, keratoacanthoma in 0.4% and malignant melanoma in situ in 0.4%. In patients who received BRAFTOVI in combination with cetuximab and FOLFIRI, skin papilloma occurred in 2.8% and keratoacanthoma in 1.4% of patients. 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 noncutaneous malignancies. Discontinue BRAFTOVI for RAS mutation-positive noncutaneous malignancies. Monitor patients for new malignancies prior to initiation of treatment, while on treatment, and after discontinuation of treatment.

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-authorized test prior to initiating BRAFTOVI.

Cardiomyopathy: Cardiomyopathy manifesting as left ventricular dysfunction associated with symptomatic or asymptomatic decreases in ejection fraction, has been reported in patients. Assess left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) scan prior to initiating treatment, 1 month after initiating treatment, and then every 2 to 3 months during treatment. The safety has not been established in patients with a baseline ejection fraction that is either below 50% or below the institutional lower limit of normal (LLN). Patients with cardiovascular risk factors should be monitored closely. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hepatotoxicity: Hepatotoxicity can occur. In the BREAKWATER trial, the incidence of Grade 3 or 4 increases in liver function laboratory tests in patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6 was 2.6% for alkaline phosphatase, and 1.3% each for ALT and AST. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, the incidence of Grade 3 or 4 increases in liver function laboratory tests was 1.5% each for ALT and AST. Monitor liver laboratory tests before initiation of BRAFTOVI, monthly during treatment, and as clinically indicated. Withhold, reduce dose, or permanently discontinue based on severity of adverse reaction.

Hemorrhage: Hemorrhage can occur. In the BREAKWATER trial, hemorrhage occurred in 34% of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6; Grade 3 or 4 hemorrhage occurred in 3% of patients. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, hemorrhage occurred in 21% of patients. 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. In BREAKWATER, the incidence of uveitis among patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6 was 0.4%. 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. In the BREAKWATER trial, an increase of QTcF >500 ms was measured in 4% (9/226) of patients receiving BRAFTOVI in combination with cetuximab and mFOLFOX6. In patients receiving BRAFTOVI in combination with cetuximab and FOLFIRI, an increase of QTcF >500 ms was measured in 1.5% (1/65) of 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 pregnant women. BRAFTOVI can render hormonal contraceptives ineffective. Advise females of reproductive potential to use effective nonhormonal contraception during treatment with BRAFTOVI and for 2 weeks after the final dose.

Risks Associated with Combination Treatment: BRAFTOVI is indicated for use as part of a regimen in combination with cetuximab and mFOLFOX6 or FOLFIRI. Refer to the prescribing information for cetuximab and individual product components of mFOLFOX6 and FOLFIRI for additional risk information.

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.

ADVERSE REACTIONS

BRAF V600E mutation-positive mCRC, in combination with cetuximab and mFOLFOX6

  • Serious adverse reactions occurred in 46% of patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6. Serious adverse reactions in >3% of patients included intestinal obstruction (4.7%), pyrexia (3.9%), sepsis (3.4%), and abdominal pain (3.4%)
  • Fatal intestinal obstruction occurred in 0.9%, and fatal large intestinal perforation and gastrointestinal perforation occurred in 0.4% (each) in patients who received BRAFTOVI in combination with cetuximab and mFOLFOX6
  • Most common adverse reactions (≥25%, all grades) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: peripheral neuropathy (64% vs 53% and 57%), nausea (54% vs 50% and 44%), fatigue (53% vs 41% and 45%), diarrhea (42% vs 50% and 44%), decreased appetite (38% vs 27% and 30%), rash (36% vs 6% and 5%), vomiting (36% vs 22% and 17%), hemorrhage (34% vs 21% and 15%), abdominal pain (32% vs 31% and 30%), arthralgia (32% vs 6% and 7%), pyrexia (29% vs 16% and 17%), and constipation (27% vs 23% and 25%)
  •  Most common laboratory abnormalities (≥10%, Grade 3 or 4) in the BRAFTOVI with cetuximab and mFOLFOX6 arm compared to the control arm (mFOLFOX6 ± bevacizumab or FOLFOXIRI ± bevacizumab or CAPOX ± bevacizumab), and a subset of the control arm (mFOLFOX6 ± bevacizumab), respectively were: increased lipase (53% vs 28% and 23%), decreased neutrophil count (37% vs 35% and 33%), decreased hemoglobin (19% vs 6% and 7%), decreased white blood cell count (12% vs 8% and 6%), and increased glucose (11% vs 2% and 1%)

BRAF V600E mutation-positive mCRC, in combination with cetuximab and FOLFIRI

  • Serious adverse reactions occurred in 39% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI. Serious adverse reactions in >3% of patients included febrile neutropenia (5.6%) and infusion related reaction (4.2%)
  • Fatal gastrointestinal perforation occurred in 1.4% of patients who received BRAFTOVI in combination with cetuximab and FOLFIRI 
  • Most common adverse reactions (>25%, all Grades) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: nausea (61% vs 57%), diarrhea (55% vs 49%), fatigue (47% vs 50%), vomiting (47% vs 31%), alopecia (35% vs 22%), constipation (31% vs 29%), abdominal pain (30% vs 22%), decreased appetite (30% vs 32%), and rash (27% vs 1.5%)
  • Most common laboratory abnormalities (≥10%, Grade 3 or 4) in the BRAFTOVI with cetuximab and FOLFIRI arm compared to the control arm (FOLFIRI ± bevacizumab) were: decreased neutrophil count (30% vs 32%), increased lipase (22% vs 12%), decreased white blood cell count (20% vs 6%), and decreased hemoglobin (10% vs 3%)
DRUG INTERACTIONS

Strong or moderate CYP3A4 inhibitors: Avoid coadministration of BRAFTOVI with strong or moderate CYP3A4 inhibitors, including grapefruit juice. If coadministration is unavoidable, reduce the BRAFTOVI dose.

Strong CYP3A4 inducers: Avoid coadministration of BRAFTOVI with strong CYP3A4 inducers.

Sensitive CYP3A4 substrates: Avoid the coadministration of BRAFTOVI with CYP3A4 substrates (including hormonal contraceptives) for which a decrease in plasma concentration may lead to reduced efficacy of the substrate. If the coadministration cannot be avoided, see the CYP3A4 substrate product labeling for recommendations.

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

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

Please see full Prescribing Information for BRAFTOVI. INDICATION AND USAGE

BRAFTOVI® (encorafenib) is indicated, in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of adult patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-authorized test.

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