Braftovi (Encorafenib)

BRAF kinase inhibitor for targeted cancer treatment

℞ Prescription Only BRAF Kinase Inhibitor Hard Capsule
Active Ingredient
Encorafenib
Available Strengths
50 mg, 75 mg
Manufacturer
Pierre Fabre Medicament
Administration
Oral, once daily
Medically reviewed: December 24, 2025 Published: May 15, 2025 Evidence level: 1A (Systematic reviews, RCTs)

Braftovi (encorafenib) is a targeted cancer therapy that blocks the activity of mutated BRAF proteins driving tumor growth. It is prescribed in combination with other anticancer agents for the treatment of BRAF V600-mutant melanoma, non-small cell lung cancer (NSCLC), and metastatic colorectal cancer. This guide provides evidence-based information on its uses, dosage, side effects, drug interactions, and important safety considerations.

Quick Facts: Braftovi

Active Ingredient
Encorafenib
Drug Class
BRAF Kinase Inhibitor
Common Uses
Melanoma, NSCLC, Colorectal Cancer (BRAF V600-mutant)
Available Forms
Hard capsules (50 mg, 75 mg)
Prescription Status
Prescription required (Rx)
Administration
Oral, once daily with or without food

Key Takeaways

  • Braftovi is always used in combination with another targeted therapy — never as monotherapy for initial treatment. It is combined with binimetinib for melanoma and NSCLC, or with cetuximab for colorectal cancer.
  • Before starting treatment, your doctor must confirm a BRAF V600 mutation through genetic testing. The medication only works in cancers with this specific mutation.
  • Common side effects include nausea, fatigue, diarrhea, joint pain, and skin reactions. Serious side effects such as cardiac problems, hemorrhage, and new skin cancers require immediate medical attention.
  • Regular monitoring is essential during treatment, including cardiac assessments, blood tests for liver and kidney function, eye examinations, and skin checks every two months.
  • Avoid grapefruit juice during treatment, as it can increase drug levels and worsen side effects. Many other medications can interact with Braftovi, so inform your doctor of all medicines you take.

What Is Braftovi and What Is It Used For?

Braftovi (encorafenib) is a targeted cancer medicine that belongs to the class of BRAF kinase inhibitors. It works by blocking mutated BRAF proteins that drive cancer cell growth, and is used in combination with other anticancer agents to treat BRAF V600-mutant melanoma, non-small cell lung cancer (NSCLC), and colorectal cancer.

Braftovi contains the active substance encorafenib, a potent and highly selective inhibitor of the BRAF serine/threonine kinase. The BRAF gene normally plays a role in regulating cell growth through the mitogen-activated protein kinase (MAPK) signaling pathway. However, when this gene develops specific mutations — known as BRAF V600E or V600K mutations — the resulting protein becomes constantly active, sending uncontrolled growth signals that drive cancer cell proliferation and survival.

By binding to and inhibiting this mutated BRAF protein, encorafenib effectively blocks the aberrant signaling cascade, slowing or stopping tumor growth. Importantly, encorafenib has a notably longer dissociation half-life from the BRAF V600E protein compared to other BRAF inhibitors such as dabrafenib and vemurafenib, meaning it remains bound to its target for an extended period, potentially enhancing its therapeutic efficacy.

Approved Indications

Braftovi is approved for the following indications, always used in combination with another targeted therapy:

Melanoma

Braftovi is used in combination with binimetinib (a MEK inhibitor, brand name Mektovi) for the treatment of adult patients with unresectable or metastatic melanoma that harbors a BRAF V600E or V600K mutation. The COLUMBUS clinical trial demonstrated that this combination achieved a median progression-free survival of 14.9 months, compared to 7.3 months with vemurafenib monotherapy. Melanoma is the most aggressive form of skin cancer, and BRAF mutations are found in approximately 40–60% of cutaneous melanomas, making BRAF-targeted therapy a cornerstone of treatment for eligible patients.

Non-Small Cell Lung Cancer (NSCLC)

In combination with binimetinib, Braftovi is approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) that harbors a BRAF V600E mutation. BRAF V600E mutations occur in approximately 1–2% of NSCLC cases. While this represents a small proportion of all lung cancers, targeted therapy with encorafenib and binimetinib offers a meaningful treatment option for patients whose cancers have spread or cannot be surgically removed.

Colorectal Cancer

Braftovi is used in combination with cetuximab (an anti-EGFR monoclonal antibody) for the treatment of adult patients with metastatic colorectal cancer (CRC) that carries a BRAF V600E mutation and who have received prior systemic therapy. The BEACON CRC trial showed that the combination of encorafenib and cetuximab significantly improved overall survival compared to standard chemotherapy. BRAF V600E-mutant colorectal cancer accounts for approximately 8–12% of all metastatic CRC cases and is associated with a particularly aggressive disease course and poor prognosis with conventional chemotherapy.

How It Works: Mechanism of Action

The MAPK/ERK signaling pathway is one of the most important cellular communication pathways that controls cell growth, proliferation, and survival. Under normal conditions, growth factor signals are transmitted from the cell surface through a chain of proteins: RAS → RAF → MEK → ERK. When BRAF carries a V600 mutation, it becomes constitutively active, meaning it continuously stimulates cell growth regardless of external signals.

Encorafenib acts as a potent ATP-competitive inhibitor of BRAF V600-mutant kinases. By blocking this mutated protein, it interrupts the aberrant signaling through the MAPK pathway. When combined with binimetinib (which inhibits MEK, the next protein in the pathway) or cetuximab (which blocks EGFR, an upstream receptor), the treatment achieves more comprehensive pathway suppression, reducing the likelihood of resistance development and improving clinical outcomes.

What Should You Know Before Taking Braftovi?

Before starting Braftovi, your doctor must confirm a BRAF V600 mutation through genetic testing. You should inform your healthcare team about all medical conditions, especially heart, liver, kidney, or eye problems, and provide a complete list of all medications you take, including herbal supplements.

Contraindications

Braftovi must not be taken if you have a known allergy (hypersensitivity) to encorafenib or any of the other ingredients in the capsule (listed in the contents section below). If you experience signs of an allergic reaction such as swelling of the face, lips, tongue, or throat, difficulty breathing, or severe skin rash, seek immediate medical attention and discontinue the medication only as directed by your healthcare provider.

Warnings and Precautions

Speak with your doctor, pharmacist, or nurse before taking Braftovi, and inform them about all your medical conditions, particularly if you have any of the following:

  • Heart problems: including any changes in the heart's electrical activity (QT interval prolongation), heart failure, or other cardiac conditions
  • Bleeding problems: or if you take any medications that may cause bleeding
  • Eye problems: any pre-existing vision disorders or retinal conditions
  • Liver or kidney problems: impaired function of either organ may affect drug metabolism and elimination
  • Other cancers: inform your doctor if you have had any type of cancer other than melanoma, colorectal cancer, or NSCLC, as Braftovi may potentially worsen certain other cancer types

Seek Immediate Medical Attention For:

  • Cardiac symptoms: dizziness, fatigue, lightheadedness, shortness of breath, pounding or irregular heartbeat, leg swelling
  • Bleeding: coughing up blood, vomiting blood or dark material resembling coffee grounds, black tarry stools, blood in urine, abdominal pain, unusual vaginal bleeding
  • Eye problems: blurred vision, vision loss, colored dots in visual field, halos around objects (when used with binimetinib)
  • Skin changes: new warts, sores, reddish bumps that bleed or do not heal, moles that change in size or color
  • Tumor lysis syndrome: nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urination, fatigue

Cardiac Monitoring

Braftovi, particularly when combined with binimetinib, can impair heart function and may reduce the left ventricular ejection fraction (LVEF). It can also alter the heart's electrical activity, causing QT interval prolongation, which can lead to dangerous heart rhythm disturbances. Your doctor will assess your heart function before starting treatment and monitor it regularly throughout therapy using echocardiograms or MUGA scans and electrocardiograms (ECGs).

Skin Cancer Surveillance

Treatment with Braftovi can paradoxically promote the development of new cutaneous malignancies, including cutaneous squamous cell carcinoma (cuSCC) and new melanomas. This phenomenon is believed to result from paradoxical activation of the MAPK pathway in cells with pre-existing RAS mutations. Your doctor will perform thorough skin examinations before treatment, every two months during treatment, and for up to six months after discontinuation. Regular CT scans will also be performed to check for internal squamous cell carcinoma. Examination of the genital area (for women) and the anal region is also recommended before and after treatment.

Hepatic and Renal Monitoring

Braftovi can cause abnormal liver enzyme elevations and changes in kidney function. Your doctor will order blood tests to monitor liver and kidney function before and during treatment. It is important to drink adequate fluids throughout treatment. Report any episodes of vomiting or signs of dehydration to your doctor promptly, as these can exacerbate renal impairment.

Pregnancy and Breastfeeding

Pregnancy

Braftovi is not recommended during pregnancy, as it may cause harm to the developing fetus, including birth defects. Women of childbearing potential must use effective contraception during treatment and for at least one month after the last dose. Importantly, hormonal contraceptives (such as oral contraceptive pills, injectable contraceptives, patches, implants, and certain hormone-releasing intrauterine devices) may have reduced effectiveness during Braftovi treatment. Therefore, a reliable barrier method of contraception (such as condoms) should be used. If you become pregnant while taking Braftovi, contact your doctor immediately.

Breastfeeding

Braftovi is not recommended during breastfeeding. It is unknown whether encorafenib is excreted in human breast milk. If you are breastfeeding or planning to breastfeed, consult your doctor before taking this medication.

Fertility

Braftovi may reduce sperm count in men, potentially affecting the ability to father a child. If fertility preservation is a concern, discuss this with your doctor before starting treatment. Options such as sperm banking may be considered.

Children and Adolescents

Braftovi is not recommended for use in children and adolescents under 18 years of age. The safety and efficacy of this medication have not been established in this age group.

Driving and Operating Machinery

Braftovi may affect your ability to drive or operate machinery. Visual disturbances, fatigue, and dizziness are potential side effects that could impair these activities. Do not drive or use machines if you experience any symptoms that affect your alertness or vision.

How Does Braftovi Interact with Other Drugs?

Braftovi (encorafenib) is metabolized primarily through the cytochrome P450 (CYP) enzyme system, particularly CYP3A4. Many commonly used medications can significantly increase or decrease encorafenib levels, potentially causing dangerous side effects or reducing efficacy. Always provide your healthcare team with a complete list of all medications, supplements, and herbal products you are taking.

Encorafenib is both a substrate and an inhibitor of several CYP enzymes and drug transporters. Its metabolism is primarily mediated by CYP3A4, CYP2C19, and CYP2D6. Consequently, medications that inhibit or induce these enzymes can significantly alter encorafenib plasma concentrations. Additionally, encorafenib itself can affect the levels of other medications by inhibiting CYP enzymes and transporters such as P-glycoprotein (P-gp) and organic anion-transporting polypeptide (OATP).

Major Interactions

The following medications can have clinically significant interactions with Braftovi and require particular attention:

Interacting Drug/Substance Category Effect on Braftovi Clinical Recommendation
Itraconazole, Posaconazole Strong CYP3A4 inhibitors Significantly increased encorafenib levels Avoid concomitant use; dose adjustment required if unavoidable
Rifampicin Strong CYP3A4 inducer Significantly decreased encorafenib levels Avoid concomitant use; may reduce efficacy
Phenytoin, Carbamazepine Strong CYP3A4 inducers Significantly decreased encorafenib levels Avoid concomitant use; consider alternative anticonvulsants
St. John's Wort (Hypericum perforatum) Herbal CYP3A4 inducer Decreased encorafenib levels Do not use during treatment
Ritonavir, Amprenavir HIV protease inhibitors (CYP3A4 inhibitors) Increased encorafenib levels Avoid or use with caution; dose reduction may be required
Grapefruit juice CYP3A4 inhibitor Increased encorafenib levels and toxicity Avoid grapefruit and grapefruit juice entirely during treatment
Amiodarone Antiarrhythmic Additive QT prolongation risk Avoid concomitant use if possible; ECG monitoring if combined

Other Notable Interactions

The following medications may also interact with Braftovi, though the clinical significance may vary:

Interacting Drug Category Clinical Recommendation
Fluconazole Moderate CYP3A4 inhibitor Use with caution; monitor for increased side effects
Clarithromycin, Erythromycin, Telithromycin Antibiotics (CYP3A4 inhibitors) Use with caution; consider alternatives
Methotrexate, Imatinib Anticancer agents Monitor closely; encorafenib may affect levels
Rosuvastatin, Atorvastatin Statins (cholesterol-lowering) Monitor for statin-related side effects (myopathy)
Hormonal contraceptives Reproductive hormones May have reduced effectiveness; use barrier methods additionally
Diltiazem, Bosentan Cardiovascular agents Monitor for altered effectiveness; dose adjustments may be needed
Raltegravir, Dolutegravir HIV integrase inhibitors Monitor for altered drug levels
Furosemide Loop diuretic Monitor renal function and electrolytes closely

Important Dietary Restriction

Do not consume grapefruit or grapefruit juice during Braftovi treatment. Grapefruit inhibits CYP3A4 enzymes in the gut wall and liver, which can significantly increase encorafenib blood levels and the risk of serious side effects.

What Is the Correct Dosage of Braftovi?

The dose of Braftovi depends on the type of cancer being treated. For melanoma and NSCLC, the recommended dose is 450 mg (six 75 mg capsules) once daily with binimetinib. For colorectal cancer, the dose is 300 mg (four 75 mg capsules) once daily with cetuximab. Always take Braftovi exactly as prescribed by your doctor.

Standard Dosing by Indication

Melanoma and NSCLC (with Binimetinib)

Dose: 450 mg (six 75 mg capsules) taken orally once daily

Combination partner: Binimetinib 45 mg twice daily

Duration: Continue treatment as long as the patient benefits or until unacceptable toxicity occurs

Colorectal Cancer (with Cetuximab)

Dose: 300 mg (four 75 mg capsules) taken orally once daily

Combination partner: Cetuximab (administered intravenously as per prescribing information)

Duration: Continue treatment as long as the patient benefits or until unacceptable toxicity occurs

Dose Adjustments

Your doctor may reduce your dose, temporarily interrupt treatment, or permanently discontinue Braftovi depending on the severity of side effects experienced. Specific dose reductions are available for patients who develop:

  • Severe cardiac toxicity (reduced LVEF or QT prolongation)
  • Significant hemorrhagic events
  • Ocular toxicity (retinal pigment epithelial detachment or other serious eye conditions)
  • Hepatotoxicity (elevated liver enzymes)
  • Renal impairment (elevated creatinine)
  • New cutaneous malignancies

If you have pre-existing liver or kidney impairment, your doctor may start you on a lower dose. The dose may be adjusted based on blood test results obtained during treatment.

How to Take Braftovi

Braftovi capsules should be swallowed whole with water. They may be taken with or without food. Follow these guidelines for optimal administration:

  • Opening blister packs: Do not push the capsule through the blister foil. Separate one blister cell by bending along the perforations, then gently peel back the foil starting from the corner marked with an arrow.
  • For patients unable to swallow whole capsules: Open the capsule and mix the contents with approximately one teaspoon (20 mL) of applesauce. Consume the entire mixture immediately. If not consumed within 30 minutes, discard and prepare a new dose.
  • Timing: Take your dose at approximately the same time each day to maintain consistent blood levels.

Missed Dose

If you miss a dose of Braftovi, take it as soon as you remember, provided the missed dose was scheduled less than 12 hours ago. If more than 12 hours have passed since the scheduled dose time, skip the missed dose entirely and take your next dose at the regular scheduled time. Do not take a double dose to compensate for a missed one.

Vomiting After a Dose

If you vomit after taking Braftovi, do not take an additional dose. Simply take your next scheduled dose at the usual time. Vomiting can be a side effect of the medication, and your doctor may prescribe antiemetic medications to help manage this symptom.

Overdose

If you take more capsules than prescribed, contact your doctor, pharmacist, or emergency services immediately. Symptoms of overdose may include worsening of known side effects such as nausea, vomiting, dehydration, and blurred vision. If possible, bring the medication packaging and this information to show the healthcare team. There is no specific antidote for encorafenib overdose; treatment is supportive and symptom-based.

Do Not Stop Treatment Without Medical Advice

It is important to continue taking Braftovi for as long as your doctor prescribes. Do not stop treatment on your own, even if you feel better or if side effects occur. Your doctor will determine if dose adjustments or treatment discontinuation is appropriate.

What Are the Side Effects of Braftovi?

Like all anticancer medications, Braftovi can cause side effects, although not everyone experiences them. Side effects vary depending on whether Braftovi is used with binimetinib (for melanoma/NSCLC) or with cetuximab (for colorectal cancer). Some side effects can be serious and require immediate medical attention.

Serious Side Effects Requiring Immediate Attention

Contact your doctor or seek emergency care immediately if you experience any of the following:

  • Cardiac dysfunction: Braftovi combined with binimetinib can reduce heart function (decreased LVEF). Watch for dizziness, unusual tiredness, shortness of breath, rapid or irregular heartbeat, and swollen legs.
  • Retinal detachment: When taken with binimetinib, fluid leakage under the retina can cause retinal layer separation. Symptoms include blurred vision, vision loss, colored spots, and halos around objects.
  • Hemorrhage: Serious bleeding events can occur. Watch for coughing up blood, vomiting blood or coffee-ground material, black tarry stools, blood in urine, abdominal pain, unexplained headache, or unusual vaginal bleeding.
  • Rhabdomyolysis: When used with binimetinib, muscle breakdown can occur, potentially leading to kidney failure. Symptoms include severe muscle pain, cramps, stiffness, and dark-colored urine.
  • New skin cancers: Cutaneous squamous cell carcinoma and new melanomas may develop during treatment. These are typically localized and can be surgically removed without stopping Braftovi.
  • Tumor lysis syndrome: Rapid tumor cell death can cause life-threatening metabolic complications. Symptoms include nausea, shortness of breath, irregular heartbeat, muscle cramps, seizures, cloudy urine, decreased urination, and fatigue.

Side Effects with Binimetinib (Melanoma and NSCLC)

Very Common

May affect more than 1 in 10 people

  • Anemia (decreased red blood cells)
  • Peripheral neuropathy (numbness, tingling, or pain in hands and feet)
  • Headache and dizziness
  • Hemorrhage (bleeding at various sites)
  • High blood pressure (hypertension)
  • Visual impairment
  • Abdominal pain, diarrhea, nausea, vomiting, constipation
  • Itching (pruritus) and dry skin
  • Hair loss or thinning (alopecia)
  • Various types of skin rash
  • Thickening of the outer skin layer (hyperkeratosis)
  • Joint pain (arthralgia), muscle pain, back pain, limb pain
  • Fever, fatigue, peripheral edema (swelling)
  • Abnormal liver function tests
  • Elevated creatine kinase (muscle enzyme)

Common

May affect up to 1 in 10 people

  • Skin papillomas (benign skin tumors)
  • Allergic reactions (facial swelling, breathing difficulty)
  • Altered taste sensation (dysgeusia)
  • Eye inflammation (uveitis)
  • Blood clots (thromboembolism)
  • Colitis (inflammation of the colon)
  • Redness or cracked skin
  • Panniculitis (inflammation of subcutaneous fat)
  • Acneiform dermatitis (acne-like rash)
  • Hand-foot syndrome (palmar-plantar erythrodysesthesia)
  • Kidney failure and elevated creatinine
  • Elevated alkaline phosphatase, amylase, lipase
  • Increased skin sensitivity to sunlight (photosensitivity)

Uncommon

May affect up to 1 in 100 people

  • Basal cell carcinoma (a type of skin cancer)
  • Facial nerve weakness and paralysis
  • Pancreatitis (inflammation of the pancreas with severe abdominal pain)

Side Effects with Cetuximab (Colorectal Cancer)

Very Common

May affect more than 1 in 10 people

  • New moles (pigmented nevi)
  • Decreased appetite and insomnia
  • Peripheral neuropathy and headache
  • Hemorrhage (bleeding at various sites)
  • Diarrhea, abdominal pain, nausea, vomiting, constipation
  • Acneiform dermatitis, various rashes, dry skin, itching
  • Joint pain, musculoskeletal pain, muscle pain, limb pain, back pain
  • Fatigue and fever

Common

May affect up to 1 in 10 people

  • Skin papillomas
  • Allergic reactions
  • Dizziness and altered taste
  • Rapid heartbeat (tachycardia)
  • Skin darkening (hyperpigmentation)
  • Hand-foot syndrome and hyperkeratosis
  • Cracked skin and hair loss
  • Kidney failure and elevated creatinine
  • Abnormal liver function tests

Uncommon

May affect up to 1 in 100 people

  • Basal cell carcinoma
  • Pancreatitis with severe abdominal pain
  • Skin peeling
  • Elevated amylase and lipase (pancreatic enzymes)

Side Effects of Braftovi Monotherapy

If your doctor temporarily discontinues binimetinib while you continue taking Braftovi alone, some side effects may occur at different frequencies. The following additional side effects are notable during Braftovi monotherapy:

  • Palmar-plantar erythrodysesthesia (hand-foot syndrome) becomes very common
  • Hyperkeratosis (skin thickening) is very common
  • Skin darkening (hyperpigmentation) is very common
  • Decreased appetite and insomnia are very common
  • Altered taste sensation (dysgeusia) is very common
  • Pigmented nevi (moles) and skin papillomas are very common
  • Rapid heartbeat (tachycardia) is common
  • Facial nerve palsy is common

Reporting Side Effects

Reporting suspected side effects after a medicine has been authorized is an important safeguard that allows continuous monitoring of the medicine's benefit-risk balance. Healthcare professionals and patients are encouraged to report any suspected adverse reactions to their national pharmacovigilance authority. In the European Union, you can report side effects through the European Medicines Agency (EMA) reporting system. In the United States, use the FDA's MedWatch program.

How Should You Store Braftovi?

Store Braftovi at or below 30°C (86°F) in the original packaging to protect from moisture. Keep out of sight and reach of children. Do not use after the expiration date printed on the carton and blister.

Proper storage of Braftovi is essential to maintain its effectiveness and safety. Follow these storage guidelines:

  • Temperature: Store at or below 30°C (86°F). Do not freeze.
  • Packaging: Keep the capsules in the original blister packaging until ready to use. The packaging is designed to protect against moisture, which can affect the medication's stability.
  • Moisture: This medication is moisture-sensitive. Do not remove capsules from the blister until immediately before taking them.
  • Expiration: Do not use after the expiration date (EXP) printed on the carton and blister pack. The expiration date refers to the last day of the indicated month.
  • Children: Keep out of sight and reach of children at all times.
  • Disposal: Do not dispose of medications in household waste or down drains. Ask your pharmacist about proper disposal methods to protect the environment.

What Does Braftovi Contain?

Braftovi capsules contain encorafenib as the active ingredient, available in 50 mg and 75 mg strengths. The capsules also contain inactive excipients necessary for manufacturing and stability.

Active Ingredient

The active substance is encorafenib. Each capsule contains either 50 mg or 75 mg of encorafenib.

Inactive Ingredients (Excipients)

The capsule contents and shell contain the following inactive ingredients:

  • Capsule contents: Copovidone (E1208), poloxamer 188, microcrystalline cellulose (E460i), succinic acid (E363), crospovidone (E1202), colloidal anhydrous silica (E551), magnesium stearate (E470b)
  • Capsule shell: Gelatin (E441), titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172)
  • Printing ink: Shellac (E904), black iron oxide (E172), propylene glycol (E1520)

Appearance and Pack Sizes

Braftovi 50 mg Hard Capsules

Orange opaque cap and flesh-colored opaque body, imprinted with a stylized "A" on the cap and "LGX 50mg" on the body. Available in packs of 28 × 1 or 112 × 1 capsules in perforated unit-dose blisters.

Braftovi 75 mg Hard Capsules

Flesh-colored opaque cap and white opaque body, imprinted with a stylized "A" on the cap and "LGX 75mg" on the body. Available in packs of 42 × 1 or 168 × 1 capsules in perforated unit-dose blisters.

Not all pack sizes may be available in every market.

Marketing Authorization Holder and Manufacturer

Marketing authorization holder: Pierre Fabre Medicament, Les Cauquillous, 81500 Lavaur, France

Manufacturer: Pierre Fabre Medicament Production, Site Progipharm, rue du Lycée, 45500 Gien, France

Frequently Asked Questions About Braftovi

Medical References

  1. European Medicines Agency (EMA). "Braftovi (encorafenib) - Summary of Product Characteristics." Last updated 2025. EMA - Braftovi Official European regulatory information and prescribing guidance.
  2. Dummer R, Ascierto PA, Gogas HJ, et al. (2018). "Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial." The Lancet Oncology. 19(5):603–615. DOI: 10.1016/S1470-2045(18)30142-6 Pivotal phase 3 trial demonstrating efficacy of encorafenib + binimetinib in BRAF-mutant melanoma. Evidence level: 1B
  3. Kopetz S, Grothey A, Yaeger R, et al. (2019). "Encorafenib, binimetinib, and cetuximab in BRAF V600E-mutated colorectal cancer." New England Journal of Medicine. 381(17):1632–1643. DOI: 10.1056/NEJMoa1908075 BEACON CRC trial establishing encorafenib + cetuximab as standard of care for BRAF V600E-mutant CRC. Evidence level: 1B
  4. National Comprehensive Cancer Network (NCCN). "Clinical Practice Guidelines in Oncology: Melanoma - Cutaneous." Version 3.2025. NCCN Guidelines Comprehensive clinical practice guidelines for melanoma treatment including BRAF-targeted therapy.
  5. European Society for Medical Oncology (ESMO). "Cutaneous melanoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up." Annals of Oncology. 2024. ESMO Guidelines European clinical practice guidelines for melanoma management.
  6. U.S. Food and Drug Administration (FDA). "Braftovi (encorafenib) - Prescribing Information." Revised 2023. FDA Label U.S. regulatory prescribing information for Braftovi.
  7. World Health Organization (WHO). "WHO Model List of Essential Medicines - 23rd List." 2023. WHO Essential Medicines WHO reference list for essential medicines in oncology.

Evidence grading: This article uses the GRADE framework (Grading of Recommendations Assessment, Development and Evaluation) for evidence-based medicine. Evidence level 1A represents the highest quality of evidence, based on systematic reviews of randomized controlled trials.

⚕️

iMedic Medical Editorial Team

Specialists in oncology, clinical pharmacology, and internal medicine

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iMedic's medical content is produced by a team of licensed specialist physicians and medical experts with solid academic background and clinical experience. Our editorial team includes:

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