This medication requires a valid prescription. Please refer to the ‘Prescription Guide’ for details.

Note: We can assist only if the medicine is unavailable in your country.”

How MitoGENE Supports Patients

MitoGENE assists Indian patients and their treating doctors by:

  • Preparing and verifying medical documentation
  • Applying for necessary import permits
  • Coordinating international supply chain and logistics
  • Ensuring safe delivery of BRAFTOVI (encorafenib) directly to the treating hospital/physician/patient

Our process is fully compliant with Indian regulatory guidelines for accessing international targeted cancer therapies.

Need Help Accessing BRAFTOVI?

If you or a loved one has a BRAF V600 mutation-positive cancer and your doctor has recommended BRAFTOVI (encorafenib), MitoGENE can guide you step by step in accessing this treatment safely and legally through the Named Patient Program in India.

Shipping:
Room Temperature Shipping. BRAFTOVI is shipped under controlled room temperature conditions (15°C to 25°C) using standard logistics procedures.

Reach out to us via the inquiry form below.

BRAFTOVI (Encorafenib)

BRAFTOVI (encorafenib) is a prescription medicine indicated for:

  • Adults with unresectable or metastatic melanoma that has a BRAF V600E or V600K mutation, as confirmed by an FDA-approved test, and in combination with binimetinib (MEKTOVI).
  • Adults with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, in combination with cetuximab, after prior therapy.

BRAFTOVI is an oral targeted therapy designed to inhibit BRAF kinase, a key protein involved in cell growth signaling in certain cancers. It is approved for medical use in the United States, European Union, Japan, and several other countries.

BRAFTOVI (encorafenib) Access in India

While BRAFTOVI (encorafenib) has received approvals in multiple regions including the U.S. and EU, it is not yet commercially available in India.
However, eligible patients diagnosed with BRAF mutation-positive metastatic melanoma or BRAF V600E mutation-positive metastatic colorectal cancer may be able to legally access BRAFTOVI in India through the Named Patient Program (NPP) — a government-regulated pathway for importing global cancer medicines for personal use when no effective local options exist.

Disease Indications:

  • Metastatic Colorectal Cancer (BRAF V600E mutation-positive)
  • Unresectable or Metastatic Melanoma (BRAF V600E or V600K mutation-positive)

Manufacturer: Pierre Fabre Medicament
Form: Oral Capsules

Medicine Approved by:

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • Pharmaceuticals and Medical Devices Agency (PMDA) Japan

Available Dosage Form & Package:

  • 75 mg capsules (bottles of 42 / 168 capsules)
  • 50 mg capsules (bottles of 28 /112 capsules)

What is BRAFTOVI (encorafenib)?

BRAFTOVI (encorafenib) is a prescription oral targeted therapy designed for adults with:

  • Unresectable or metastatic melanoma carrying BRAF V600E or V600K mutations, when used with MEKTOVI (binimetinib).
  • Metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, when used with cetuximab, after prior therapy.

It is available as oral capsules (50 mg and 75 mg), taken under the supervision of a qualified healthcare professional.
For patients in India, access to BRAFTOVI may be possible through the Named Patient Program — a legal pathway to import approved global medicines for personal use when local treatment options are limited.

How Does BRAFTOVI (encorafenib) Work?

BRAFTOVI specifically targets and inhibits BRAF V600E and V600K mutant kinases, blocking abnormal signaling pathways that drive cancer growth. When used in combination with MEKTOVI (binimetinib) for melanoma or with cetuximab for colorectal cancer, BRAFTOVI helps reduce tumor progression and improve clinical outcomes.

Important Safety Information & Common Side Effects

Serious Warnings and Precautions:

  • New Primary Malignancies: Cutaneous and non-cutaneous cancers may develop; routine monitoring is recommended.
  • QT Prolongation: May cause abnormal heart rhythm; ECG and electrolytes should be monitored.
  • Hemorrhage: Can occur in rare cases; report signs of bleeding immediately.
  • Ocular Toxicities: Uveitis and retinal vein occlusion have been reported; regular eye exams are advised.
  • Embryo-Fetal Toxicity: May harm an unborn baby; effective contraception is required during treatment and for 2 weeks after the last dose.

Common Side Effects (may vary based on combination therapy):

  • Fatigue
  • Nausea, vomiting, abdominal pain
  • Arthralgia (joint pain), myalgia (muscle pain)
  • Rash, dry skin, alopecia
  • Increased liver enzymes (AST, ALT)
  • Peripheral neuropathy (numbness or tingling)
  • Diarrhea or constipation
  • Cough
  • Decreased appetite

This is not a complete list of side effects. Patients should speak with their doctor or pharmacist for full safety information.

Where Has BRAFTOVI (encorafenib) Been Approved?

  • United States: FDA approval for BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma (in combination with binimetinib) and BRAF V600E mutation-positive mCRC (in combination with cetuximab).
  • European Union: EMA approval for similar indications.
  • Japan: PMDA approval.

In India, BRAFTOVI is not commercially available but may be accessed legally through Named Patient Program.

References

  1. FDA Prescribing Information for BRAFTOVI (encorafenib)
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210496lbl.pdf
  2. Pfizer Oncology – BRAFTOVI + MEKTOVI for BRAF-mutant Melanoma
    https://www.pfizeroncology.com/braftovi
  3. FDA Approval of BRAFTOVI + Cetuximab for BRAF V600E Mutant Metastatic Colorectal Cancer
    https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-encorafenib-cetuximab-braf-v600e-mutant-metastatic-colorectal-cancer
  4. European Medicines Agency – BRAFTOVI Summary of Product Characteristics
    https://www.ema.europa.eu/en/documents/product-information/braftovi-epar-product-information_en.pdf

Disclaimer: BRAFTOVI (encorafenib) is not approved for commercial sale in India. Access is provided strictly for personal use under physician supervision in accordance with Indian regulatory guidelines through the Named Patient Program (NPP). MitoGENE does not market, advertise, or sell unapproved drugs. All content is for informational purposes and not a substitute for professional medical advice.

How to Access BRAFTOVI (encorafenib) in India in 4 Simple Steps with MitoGENE via the Named Patient Program (NPP)?

If BRAFTOVI (encorafenib) is not yet approved or commercially available in India, MitoGENE can assist you in accessing it legally through the Named Patient Program (NPP). Here’s how the process works:

    Upload Prescription

    Upload Patient Consent Form

    Patient Consent Form
    Download

    Please download and complete this form, including your signature, and attach it to the request form or email it to info@mitogene.org along with the patient details.