Braftovi: What Patients Should Know Before Starting Targeted Cancer Treatment 

Introduction

Starting a new cancer treatment can bring up a lot of questions, emotions, and uncertainty. If your doctor has recommended Braftovi as part of your treatment plan, it’s completely normal to want a clearer understanding of what to expect. From learning how the treatment fits into your overall care journey to understanding day-to-day considerations, having the right information can help you feel more prepared and confident as you begin.

What Is Braftovi?

Braftovi® contains encorafenib, a medicine that targets a specific protein called BRAF kinase, which can play a role in the growth of certain cancers. It is used together with binimetinib, another targeted therapy, in the treatment of advanced and metastatic malignant melanoma.¹

What Is Braftovi Used For?

BRAFTOVI is a targeted cancer medicine used together with binimetinib to treat certain types of advanced melanoma (skin cancer) that cannot be removed with surgery or has spread to other parts of the body.²

It is specifically used in patients whose cancer has a BRAF V600E or BRAF V600K mutation, identified through an FDA-approved test. BRAFTOVI is not used for melanoma without these BRAF mutations.²

How Does Braftovi Work As A Targeted Cancer Treatment?

Braftovi® (encorafenib) is a targeted cancer treatment that works by blocking mutated forms of BRAF, a serine/threonine kinase involved in the MAP kinase pathway, which helps control cell growth and proliferation.¹

BRAF functions early in the RAS-RAF-MEK-ERK signaling cascade, an important intracellular pathway that sends growth signals within cells. In several cancers, including at least 50% of melanoma cases, BRAF can become mutated, leading to abnormal signaling that promotes uncontrolled cancer cell growth.¹

^{By inhibiting these mutated BRAF forms, encorafenib targets a key driver involved in tumor cell proliferation.1}

Why BRAF Mutation Testing Matters Before Starting Braftovi?

BRAFTOVI is specifically indicated for patients with unresectable or metastatic melanoma that has a BRAF V600E or BRAF V600K mutation, confirmed through an FDA-approved test. Because of this, BRAF mutation testing is an important step before starting treatment.^1,2

BRAFTOVI is not indicated for patients with wild-type BRAF melanoma, meaning it is not intended for melanoma cases without these specific mutations.^1,2

Braftovi For Melanoma

BRAFTOVI® (encorafenib), used together with binimetinib, is a treatment option for people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma. These medicines work by targeting two different parts of the RAS/RAF/MEK/ERK pathway, which helps melanoma cells grow and spread. In research studies, the combination showed stronger anti-tumor activity and delayed treatment resistance compared to either medicine used alone.²

The combination was studied in the COLUMBUS trial (NCT01909453), where patients received either BRAFTOVI with binimetinib or vemurafenib. Patients receiving the BRAFTOVI combination had a median progression-free survival (PFS) of 14.9 months, compared with 7.3 months with vemurafenib. The overall response rate (ORR) was also higher at 63%, compared with 40% for vemurafenib. In total, 577 patients participated in the study, and all had melanoma with a confirmed BRAF mutation.²

Braftovi For Metastatic Colorectal Cancer

Braftovi® (encorafenib), used together with cetuximab and fluorouracil-based chemotherapy, is approved for adults with metastatic colorectal cancer (CRC) with a BRAF V600E mutation. The approval was based on the BREAKWATER trial in patients with previously untreated metastatic CRC.³

In the study, patients receiving Braftovi with cetuximab and mFOLFOX6 chemotherapy had a median progression-free survival of 12.8 months, compared with 7.1 months in the control group. Median overall survival was 30.3 months versus 15.1 months, respectively. The treatment combination also showed a higher response rate of 61%, compared with 40% in the control arm.³

Another part of the BREAKWATER study evaluated Braftovi with cetuximab and FOLFIRI chemotherapy. In this group, the response rate was 64%, compared with 39% in the control arm.³

Braftovi For Non-Small Cell Lung Cancer

On October 11, 2023, the FDA approved BRAFTOVI® (encorafenib) with binimetinib (Mektovi®) for adults with metastatic non-small cell lung cancer (NSCLC) that carries a BRAF V600E mutation, confirmed through an FDA-approved test. FDA also approved companion diagnostic tests, including FoundationOne CDx, to help identify eligible patients.⁴

The combination was studied in the PHAROS trial involving 98 patients with metastatic NSCLC and a BRAF V600E mutation. Patients received treatment until the cancer progressed or side effects became unacceptable. Among patients who had not received previous treatment, 75% responded to treatment. Among previously treated patients, 46% responded to treatment, and the response lasted a median of 16.7 months.⁴

Braftovi Dosage: What Patients Should Know

BRAFTOVI® dosing is based on confirmed BRAF V600E or V600K mutation-positive melanoma and is typically given in combination with binimetinib. Here are some important dosage-related points patients should know:²

  - Recommended dose: BRAFTOVI 450 mg orally once daily with binimetinib

  - Before starting treatment: Tumor testing is required to confirm a BRAF V600E or V600K mutation

  - If binimetinib is withheld: Reduce BRAFTOVI to a maximum of 300 mg once daily until binimetinib is resumed

  - Drug interactions: Strong or moderate CYP3A4 inhibitors should be avoided when possible, as they may require BRAFTOVI dose adjustments

How To Take Braftovi Safely

BRAFTOVI can be taken with or without food. If a dose is missed, it should not be taken within 12 hours of the next scheduled dose. If vomiting occurs after taking BRAFTOVI, patients should not take an extra dose and should continue with the next scheduled dose instead.²

Common Side Effects Of Braftovi

Common side effects of treatment include:¹

  - Fatigue

  - Nausea

  - Joint pain (arthralgias)

  - Rash

  - Hair loss (alopecia)

  - Photosensitivity

  - Itching (pruritus)

  - Skin papilloma

Serious Side Effects And Warning Signs

  - Less common but potentially serious side effects include:¹

  - New primary malignancies (cutaneous and non-cutaneous)

  - Hemorrhage (bleeding)

  - Uveitis and other ocular toxicities

  - Rhabdomyolysis

  - QTc interval prolongation

  - Embryo-fetal toxicity

Who Should Speak To A Doctor Before Taking Braftovi?

Before starting BRAFTOVI®, it is important for certain individuals to discuss their medical condition, pregnancy status, or treatment considerations with a doctor to better understand whether the medicine is appropriate for them.²

  - Pregnant women: Based on its mechanism of action, BRAFTOVI can cause fetal harm when used during pregnancy. Animal studies showed embryo-fetal developmental changes and pregnancy loss at certain exposure levels.

  - Women who are breastfeeding: Women are advised not to breastfeed during treatment and for 2 weeks after the final dose because of the potential for serious adverse reactions in breastfed infants.

  - Females of reproductive potential: Pregnancy status should be verified before starting treatment. Effective contraception is advised during treatment and for 2 weeks after the final dose. Non-hormonal contraception is recommended because BRAFTOVI may reduce the effectiveness of hormonal contraceptives.

  - Men concerned about fertility: Based on animal studies, BRAFTOVI may impact male fertility at certain exposure levels.

  - Parents or caregivers of children: The safety and effectiveness of BRAFTOVI have not been established in pediatric patients.

  - Older adults: Clinical trials included patients aged 65 years and older, and no overall differences in safety or effectiveness were observed compared with younger patients.

  - People with liver impairment: No dose adjustment is recommended for mild hepatic impairment (Child-Pugh Class A), but recommended doses have not been established for moderate or severe hepatic impairment.

  - People with kidney impairment: No dose adjustment is recommended for mild to moderate renal impairment, but a recommended dose has not been established for severe renal impairment.

Can Braftovi Interact With Other Medicines?

Yes, BRAFTOVI® may interact with certain medicines, which can affect how well it works or increase the risk of side effects. Because of this, patients should inform their healthcare provider about all prescription medicines, over-the-counter medicines, and supplements they are taking before starting treatment.²

  - Strong or moderate CYP3A4 inhibitors may increase encorafenib plasma concentrations and increase the risk of adverse reactions. Grapefruit juice should also be avoided.

  - Strong or moderate CYP3A4 inducers may decrease encorafenib plasma concentrations and reduce treatment effectiveness.

  - BRAFTOVI may affect sensitive CYP3A4 substrate medicines, potentially increasing toxicity or reducing their efficacy.

  - Hormonal contraceptives may become less effective when used with BRAFTOVI due to reduced concentrations.

  - BRAFTOVI is associated with dose-dependent QTc interval prolongation, so medicines known to prolong the QT/QTc interval should be avoided during treatment.

What To Ask Your Doctor Before Starting Braftovi

Before starting BRAFTOVI®, it can help to have an open discussion with your doctor about the treatment plan, monitoring, daily routine, and what to expect during therapy. Asking questions beforehand may help you feel more informed and prepared throughout the treatment journey.

  - Why is BRAFTOVI being considered for my treatment plan?

  - How is BRAFTOVI usually taken and scheduled?

  - Will BRAFTOVI be used alone or with another medicine?

  - What tests or monitoring may be needed during treatment?

  - Are there any medicines, supplements, or foods I should avoid?

  - What side effects should I be aware of during treatment?

  - How often will follow-up visits be needed?

  - Are there any lifestyle or routine changes I may need to plan for?

  - What should I do if I miss a dose or have concerns during treatment?

  - What support options are available for treatment access or coordination?

Final Thoughts

BRAFTOVI® is a targeted treatment option used in specific cancers with a confirmed BRAF V600 mutation, including melanoma, metastatic colorectal cancer, and metastatic non-small cell lung cancer.²⁻⁴ Because treatment decisions depend on factors such as mutation testing, combination therapy, dosing, monitoring, and possible drug interactions, discussing the full treatment plan with a qualified healthcare provider is an important step before starting therapy.²

References

1. LiverTox®: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Encorafenib. [Updated 2019 Apr 15]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547988/
2. Braftovi Prescribing Information
3. U.S. Food and Drug Administration. FDA grants traditional approval to encorafenib for metastatic colorectal cancer with BRAF V600E mutation. Published February 24, 2026. Accessed May 15, 2026. FDA announcement
4. U.S. Food and Drug Administration. FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation. Published October 11, 2023. Accessed May 15, 2026.

Note:

The information provided is for education purpose only and is subjected to prescribing information of the drug and the guidance of your treating physician. Always consult your health care provider before making any medical decision for starting your treatment.

Disclaimer:

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