Braftovi (encorafenib): Uses, Side Effects, Dosage & Reviews

Cancer develops when genetic changes disrupt the normal controls that regulate how cells grow and divide.¹ One of the key drivers identified in cutaneous melanoma – a type of skin cancer – is a mutation in the BRAF gene, most commonly the V600E or V600K alteration (a substitution at position 600 of the BRAF protein). These pathogenetic variants of the oncogene BRAF affect the mitogen-activated protein kinase (MAPK) pathway, a critical signalling pathway that regulates cell proliferation and survival.²

When BRAF is permanently switched on, it continuously stimulates the MAPK pathway. This abnormal signalling results not only in uncontrolled tumour cell growth, but can also help cancer cells survive longer, spread to other parts of the body, and avoid detection by the immune system. Because of this central role in tumour biology, BRAF V600 mutations are considered important therapeutic targets.²

Targeted treatments have therefore been developed to interrupt this abnormal signalling in cancers that contain these mutations. One such therapy is Braftovi (encorafenib), a selective BRAF inhibitor approved for use in cancers with specific BRAF V600 mutations.³ It is typically prescribed as part of combination therapy, where multiple drugs work together to block cancer growth more effectively and help delay treatment resistance.

What is Braftovi and How It Works?

Braftovi is an oral cancer medicine containing encorafenib, a targeted inhibitor of the mutant BRAF protein. It is designed to block the abnormal BRAF kinase in tumours with a confirmed BRAF V600 mutation.⁴

Because cancer cells can activate related pathways to escape single-target blockade, Braftovi is typically used in combination with other agents to improve effectiveness.^2,3

It is used with binimetinib, which blocks another key step in the same growth pathway. Together, these medicines provide stronger tumour control and help delay resistance compared with either medicine alone.⁴

In colorectal cancer with a BRAF mutation, cancer cells may activate the MAPK pathway via another route – the epidermal growth factor receptor (EGFR) signalling mechanism – as a resistance mechanism. Combining Braftovi with cetuximab, which targets EGFR, improves tumour control compared with using either medicine alone.⁴

By targeting BRAF and related growth pathways at the same time, these combinations aim to provide more effective and longer-lasting tumour control.

Approved Indications for Braftovi

Braftovi has been approved for the following indications⁴:

Melanoma

Braftovi is indicated with binimetinib for the treatment of adults with unresectable or metastatic melanoma with a BRAF V600 mutation.

Colorectal Cancer

Braftovi is approved with cetuximab, with or without chemotherapy, for adults with metastatic colorectal cancer harbouring a BRAF V600E mutation.

Non-Small Cell Lung Cancer (NSCLC)

Braftovi, in combination with binimetinib, is indicated for adults with metastatic NSCLC with a confirmed BRAF V600E mutation.

These indications are based on confirmed BRAF V600 mutation status. Testing for this mutation is therefore required before treatment.⁴

Who Can Take Braftovi (BRAF Mutation Testing)

Braftovi is only effective in tumours that have a BRAF V600 mutation. This mutation must be confirmed before starting treatment using validated molecular tests.⁵ Without this mutation, Braftovi is not indicated, as the drug targets the abnormal BRAF protein specifically.

Braftovi Dosage

The dose of Braftovi depends on the type of cancer being treated and the medicines it is combined with⁴:

Melanoma or NSCLC: Braftovi is taken once daily together with binimetinib.
Colorectal cancer with a BRAF mutation: Braftovi is taken once daily in combination with cetuximab, sometimes along with chemotherapy.

Your doctor will decide the exact dose and treatment plan based on your specific diagnosis and overall health.⁴

Treatment usually continues as long as it is effectively controlling the cancer and side effects remain manageable. If needed, your healthcare team may adjust the dose or temporarily pause treatment.

How to Take Braftovi

Braftovi is taken by mouth once daily, exactly as prescribed by your doctor. It can be taken with or without food. Swallow the capsules whole.^4,5

If you miss a dose, take it as soon as you remember on the same day. However, if it is close to the time of your next dose, skip the missed dose and continue with your regular schedule. Do not take an extra dose to make up for a missed one.^4,5

If you vomit after taking a dose, do not take an additional dose. Take your next scheduled dose at the usual time.^4,5

Always follow your healthcare provider’s instructions carefully and contact your doctor if you are unsure about how or when to take your medication.⁴

Understanding Side Effects and Safety Monitoring

Like all cancer treatments, Braftovi can cause side effects. These vary depending on whether it is used with binimetinib or cetuximab.

When Braftovi is taken with binimetinib, commonly reported side effects include tiredness, nausea, vomiting, diarrhoea, stomach pain, joint or muscle pain, and sometimes rash or changes in vision.⁴

When used with cetuximab for colorectal cancer, side effects include fatigue, nausea, diarrhoea, reduced appetite, abdominal pain, or skin reactions such as rash or acne-like dermatitis. If chemotherapy is also included, numbness or tingling in the hands and feet may occur.⁴

Many side effects can be managed effectively, so it’s important to inform your doctor about any new or worsening symptoms. To help ensure treatment remains safe and effective, your healthcare team will carry out regular monitoring, which may include^4,5

Blood tests to check for kidney health
Heart function checks
Liver function tests
Skin examinations

Women who are pregnant or planning pregnancy should discuss potential risks with their doctor, as Braftovi may harm an unborn baby. Your doctor will also review other medications you are taking to help avoid possible interactions.⁴

Accessing Braftovi in India Through the Named Patient Program

Braftovi is approved in several countries for the treatment of cancers with confirmed BRAF V600 mutations. However, availability may vary across regions in India. In situations where suitable local treatment options are limited, eligible patients may be able to access Braftovi through the Named Patient Program (NPP).⁶

Under the NPP, a treating doctor can request Braftovi for an individual patient by submitting relevant medical records and a clinical justification for its use. This process involves regulatory permissions and import coordination before the medicine is supplied directly to the hospital or treatment centre.

To help navigate this process, Rx4U supports patients and caregivers by assisting with documentation, coordinating with healthcare providers, and managing import and delivery logistics. This support can help reduce administrative delays and allow treatment to begin as smoothly as possible.

Final Takeaway

- Braftovi is a targeted treatment designed for cancers with confirmed BRAF V600 mutations.

- It is used in combination with other therapies to improve tumour control and help delay resistance.

- Access in India may be possible through the NPP with physician approval.

- Services such as Rx4U can assist with the documentation and import process where required.

Frequently Asked Questions

1. How do I know if Braftovi is right for me?

Braftovi is only suitable for cancers that test positive for a BRAF V600 mutation. Your doctor will perform or review molecular testing before considering this treatment.⁴

2. Is Braftovi used alone?

No. Braftovi is approved for use in combination with other medicines, such as binimetinib or cetuximab, depending on the type of cancer.⁴

3. Can Braftovi be used during pregnancy?

Braftovi may harm an unborn baby. Women who are pregnant or planning pregnancy should discuss risks and appropriate precautions with their doctor.⁴

Medical Disclaimer

This information is provided for educational purposes only and is not a substitute for professional medical advice. Braftovi should only be taken under the guidance of a qualified healthcare provider. Patients should always consult their doctor or pharmacist for advice on diagnosis, treatment, and medication use, and should not make changes to their prescribed therapy without medical supervision.

References:

- What is cancer? National Cancer Institute. Updated October 11, 2021. Accessed February 19, 2026. https://www.cancer.gov/about-cancer/understanding/what-is-cancer

- Castellani G, Buccarelli M, Arasi MB, et al. BRAF mutations in melanoma: biological aspects, therapeutic implications, and circulating biomarkers. Cancers (Basel). 2023;15(16):4026. doi:10.3390/cancers15164026

- European Medicines Agency. Updated November 5, 2025. Accessed February 19, 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/braftovi

- Prescribing information. Array BioPharma Inc. 2024. Accessed February 19, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210496s018lbl.pdf

- Summary of product characteristics. Accessed February 19, 2026. https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf

- Patil S. Early access programs: benefits, challenges, and key considerations for successful implementation. Perspect Clin Res. 2016;7(1):4-8. doi:10.4103/2229-3485.173779

Note:

Disclaimer:

Rx4U procures prescribed medicines directly from manufacturers or authorized distributors. It does not claim ownership of any trademarks and complies with the provisions of the Trademark Act, 1999, particularly Sections 30 and 30(1) concerning ‘Fair Use’. It solely facilitates access to new launches through named patient import.