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Braftovi

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Braftovi

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Medicine Name: Braftovi
Generic Name (API): Encorafenib
Dosage Form & Strength: 50 mg, 75 mg
Route: Oral (swallowed whole, with or without food)
Drug Class: Kinase inhibitor — BRAF (V600E) inhibitor

Manufacturer / Innovator:

USA

Regulatory Approval:

  • FDA (US)
  • EMA (Europe)
  • PMDA (Japan)
  • NMPA (China)
  • and others
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Braftovi (Encorafenib) Capsules: Key Information for Patients


Braftovi (encorafenib) is an oral kinase inhibitor that targets BRAF V600E and related mutant BRAF kinases in the MAPK signalling pathway. Mutations in the BRAF gene, such as BRAF V600E, produce constitutively activated BRAF kinases that continuously stimulate tumour cell growth. By inhibiting these kinases, Braftovi interrupts the growth signal and slows tumour proliferation. It is almost always used in combination with another agent — binimetinib (Mektovi®) or cetuximab (Erbitux®) with chemotherapy — depending on the tumour type. Braftovi is indicated for:


  • Melanoma — in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. This was the original approval, granted by the US FDA on 27 June 2018.

  • Metastatic colorectal cancer (mCRC) — in combination with cetuximab and fluorouracil-based chemotherapy (mFOLFOX6 or FOLFIRI), for the treatment of adult patients with metastatic colorectal cancer harbouring a BRAF V600E mutation. The FDA granted traditional (full) approval for this first-line combination on 24 February 2026, based on the Phase III BREAKWATER trial, converting the accelerated approval granted in December 2024. In the pivotal portion of BREAKWATER, the Braftovi combination demonstrated a 51% reduction in the risk of death and a 47% reduction in the risk of disease progression or death compared with chemotherapy with or without bevacizumab. Braftovi in combination with cetuximab alone also remains approved for adult patients with BRAF V600E-mutant mCRC after prior therapy (approved April 2020).

  • Metastatic non-small cell lung cancer (NSCLC) — in combination with binimetinib, for the treatment of adult patients with metastatic NSCLC with a BRAF V600E mutation. This indication was approved by the FDA on 11 October 2023.


Limitations of Use: Braftovi is not indicated for the treatment of patients with wild-type BRAF melanoma, wild-type BRAF colorectal cancer, or wild-type BRAF NSCLC.


Important: Braftovi is a biomarker-directed therapy. Eligibility requires laboratory confirmation of a BRAF V600E (or, in melanoma, V600K) mutation. It is a prescription anticancer medicine and must be used under the supervision of a qualified medical oncologist.


Recommended Dosage:


Braftovi is taken orally once daily, at approximately the same time each day, with or without food. The capsules should be swallowed whole and should not be opened, crushed or chewed. The dose depends on the indication and the combination partner:

  • Melanoma and NSCLC (with binimetinib): The recommended dosage is 450 mg (six 75 mg capsules) orally once daily, in combination with binimetinib, continued until disease progression or unacceptable toxicity. Braftovi 450 mg once daily as a single agent is not recommended; if binimetinib is temporarily withheld, the Braftovi dose should be reduced to a maximum of 300 mg once daily until binimetinib is resumed.
  • BRAF V600E-mutant metastatic colorectal cancer (with cetuximab ± chemotherapy): The recommended dosage is 300 mg (four 75 mg capsules) orally once daily, in combination with cetuximab, or with cetuximab plus mFOLFOX6 or FOLFIRI, continued until disease progression or unacceptable toxicity.

For adverse reactions, the dose may be reduced in defined steps, or treatment interrupted or permanently discontinued, as set out in the prescribing information. A missed dose should not be taken within 12 hours of the next scheduled dose. If vomiting occurs after taking Braftovi, no additional dose should be taken — treatment should continue at the next scheduled dose. Dose adjustments are also required with strong or moderate CYP3A4 inhibitors, and concomitant strong CYP3A4 inducers should be avoided.


Refer to the prescribing information for binimetinib, cetuximab and chemotherapy agents for their respective dosing. The safety and effectiveness of Braftovi have not been established in paediatric patients.


This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.

Braftovi Warnings and Precautions

  • Treatment with Braftovi may increase the risk of developing new skin cancers and other cancers. Your doctor will check your skin before, during, and after treatment. Report any new skin growths, sores, or changes in existing moles immediately.
  • This medicinal product works only in cancers with a confirmed BRAF V600E or V600K mutation. Your doctor will perform an approved genetic test before starting treatment to ensure this medicine is suitable and effective for your condition.
  • Braftovi, especially with binimetinib, may reduce the heart's pumping ability. Your doctor will monitor your heart before and during treatment. Report shortness of breath, swollen ankles, tiredness, or an irregular heartbeat immediately.
  • Encorafenib may affect liver function. Regular blood tests will be performed before and during treatment. Tell your doctor immediately if you notice yellowing of the skin or eyes, dark urine, severe tiredness, or abdominal pain.
  • Therapy with Encorafenib may cause serious bleeding, including in the stomach, intestines, or brain. Seek medical attention immediately if you notice unusual bruising, blood in stools, urine, or vomit, coughing up blood, or severe headaches.
  • This medicine may cause eye conditions such as uveitis, iritis, or iridocyclitis. Regular eye examinations are recommended. Contact your doctor immediately if you experience blurred vision, eye pain, redness, or any changes in vision.
  • Braftovi may affect your heart rhythm by prolonging the QT interval. Your doctor may monitor your ECG and blood electrolytes during treatment, especially if you take other medicines that can affect heart rhythm.
  • Encorafenib may harm an unborn baby. Use effective non-hormonal contraception during treatment and as advised after the last dose. Avoid breastfeeding during treatment and for two weeks afterward. Braftovi may also affect male fertility.
  • This drug can interact with many medicines, herbal supplements, and certain foods. Always inform your doctor and pharmacist about all prescription medicines, over-the-counter products, vitamins, and supplements before starting treatment.
  • Braftovi is often given with binimetinib, cetuximab, or chemotherapy. The safety warnings, precautions, monitoring, and possible side effects of these medicines also apply, so follow your healthcare provider's instructions carefully.

How to Access Braftovi in India: A 6-Step Process

  • Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.
  • Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements — including confirmation of the BRAF V600E mutation report — to ensure a compliant pathway.
  • Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.
  • Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.
  • Step 5 – Compliant import & handling: The medicine is sourced and transported under strict GDP-compliant, controlled-temperature conditions to maintain product integrity.
  • Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Access This Process Easily via Our App

You can manage the entire process seamlessly through the Named Patient Program App, available on both the Play Store and App Store.

  • Track your medicine request in real-time
  • Upload documents and approvals
  • View quotations and timelines
  • Get status updates at every step

You can also access detailed information by clicking Login in the website header. On mobile, open the hamburger menu (☰) and tap Login from the dropdown to get started.

Documentation & Availability

What documents are required to import BRAFTOVI to India?

BRAFTOVI (encorafenib) capsules may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:
  • A valid prescription from a qualified doctor
  • The patient's diagnostic reports, including the molecular/genomic test report confirming a BRAF V600E (or V600K) mutation
  • Patient ID proof (issued by the Government of India)

How is the order confirmed?

The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.

Is BRAFTOVI available in India?
BRAFTOVI (encorafenib capsules) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, BRAFTOVI is not commercially marketed in India.

However, patients in India can legally access BRAFTOVI through the Named Patient Program (NPP) — an import provision that allows a medicine not yet registered in India to be imported in the name of an individual patient, on the prescription of their treating physician.

NamedPatientProgram.com (NPP) act as a facilitator under named patient supply, providing input on:
Availability of Braftovi in India and pathways to access it
Availability in Gulf countries (Bahrain, Oman, Qatar, Kuwait, Iraq, Saudi Arabia, and the UAE)
Braftovi price in India under the NPP route
Sourcing from genuine, reliable channels in the USA, Europe, China, Singapore, Canada, and Australia
Ensuring full transparency throughout the process

BRAFTOVI can be made available to patients, doctors, and hospitals across major cities in India, including Gurgaon, Delhi, Bangalore, Mumbai, Navi Mumbai, Thane, Hyderabad, Mysore, Kerala, Chennai, Coimbatore, Madurai, Kolkata, Ahmedabad, Surat, Vadodara, Pune, Nagpur, Nashik, Jaipur, Udaipur, Lucknow, Kanpur, Gorakhpur, Chandigarh, Mohali, Faridabad, Noida, Ghaziabad, Kochi, Trivandrum, Kozhikode, Thrissur, Kannur, Mangalore, Bhubaneswar, Patna, Ranchi, Raipur, Guwahati, Visakhapatnam, Vijayawada, Goa, Jammu, Srinagar, Dehradun, Bhopal, Indore, Ludhiana, Amritsar, and others — and can facilitate delivery to the patient's treating hospital. Orders are confirmed only upon receipt of a valid doctor's prescription and, where applicable, an import permit.

Sourcing & Delivery of Braftovi

NamedPatientProgram.com (NPP) can source Braftovi from reliable global manufacturers and qualified pharmaceutical supply channels and facilitate supply to patients, doctors, and hospitals under applicable legal provisions. As an oral solid dosage form, Braftovi is shipped under GDP-compliant controlled room-temperature conditions with full batch traceability and tamper-evident, sealed original packaging.

All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.

For Braftovi cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.

Availability of Braftovi® Across Major Cities in India

Patients across India can access Braftovi® through regulated import pathways, with delivery arranged to the treating hospital or patient based on a valid oncologist's prescription.

Mumbai: A major oncology hub with institutions like Tata Memorial, Mumbai, sees high demand for biomarker-driven therapies like Braftovi®. Access is often coordinated for patients undergoing specialized colorectal, melanoma and lung cancer care.

Bangalore: With a growing network of multispecialty hospitals and molecular diagnostic laboratories, Bangalore supports access to global targeted therapies through structured import pathways guided by treating specialists.

Delhi: As part of the Delhi NCR region, the city has a strong concentration of cancer centers and medical oncologists, making it a key location for accessing advanced imported therapies.

Gurgaon: Home to leading hospitals like Medanta, Gurgaon plays an important role in facilitating access to innovative cancer treatments through coordinated care pathways.

Noida: With proximity to Delhi and access to top hospitals, Noida patients benefit from streamlined logistics and specialist-driven treatment planning.

Hyderabad: Hyderabad's advanced healthcare infrastructure and precision oncology expertise support patients seeking access to internationally approved cancer therapies.

Chennai: Known for its established medical ecosystem, Chennai attracts patients from across India for complex cancer treatments and specialized drug access.

Kolkata: A key eastern healthcare hub, Kolkata offers access to advanced oncology care through leading hospitals and treatment centers.

Ahmedabad: Ahmedabad's expanding healthcare sector and oncology facilities support patients requiring advanced and imported cancer therapies.

Pune: With reputed hospitals and a growing cancer care infrastructure, Pune is an emerging center for access to specialized oncology treatments.

Chandigarh: Serving North India, Chandigarh provides access to advanced medical care through reputed institutions and specialist-led treatment planning.

Jaipur: Jaipur's improving healthcare network enables patients to explore access to innovative cancer therapies through structured import processes.

Lucknow: As a major city in North India, Lucknow supports access to advanced oncology treatments through both public and private healthcare institutions.

Indore: Indore is emerging as a regional healthcare hub, offering access to specialized cancer care and modern treatment pathways.

Bhopal: Patients in Bhopal can access advanced cancer treatments through the growing healthcare infrastructure and referral networks.

Nagpur: Nagpur serves as a central hub for patients across Vidarbha, with increasing access to oncology care and specialized therapies.

Surat: Surat's developing healthcare ecosystem supports patients seeking access to global oncology treatments through coordinated care.

Patna: As a major city in Eastern India, Patna provides growing access to cancer treatment through expanding hospital networks.

Coimbatore: Coimbatore is known for quality healthcare services, offering access to advanced oncology treatments in South India.

Kochi: With modern hospitals and specialist care, Kochi enables patients to explore access to internationally approved cancer therapies.

Note: Access timelines may vary depending on documentation, regulatory approvals, and sourcing logistics.

Access/Buy Braftovi® at Leading Hospitals in India

Braftovi® is typically used in advanced melanoma, colorectal and lung cancer settings where molecular testing guides treatment, and can be accessed at leading hospitals across India, where specialists guide treatment decisions and coordinate patient-specific access pathways.

Major Hospitals Covered:

  • Tata Memorial Centre: One of India's premier cancer institutes, Tata Memorial plays a key role in managing BRAF-mutant colorectal, melanoma and lung cancer cases and guiding patients toward advanced therapies like Braftovi®.
  • AIIMS: As a leading government medical institution, AIIMS provides comprehensive cancer care and supports patients requiring access to specialized and emerging treatments.
  • Apollo Hospitals: With a nationwide presence, Apollo Hospitals offers advanced oncology services and facilitates access to global treatment options through its extensive medical network.
  • Fortis Healthcare: Fortis hospitals are equipped with modern cancer care facilities and multidisciplinary teams that manage complex treatment pathways for patients.
  • Max Healthcare: Max Healthcare is known for its strong medical oncology departments, providing access to innovative targeted therapies under expert clinical supervision.
  • Manipal Hospitals: Manipal Hospitals supports advanced cancer care through experienced specialists and structured treatment planning across multiple cities.
  • Kokilaben Dhirubhai Ambani Hospital: A leading private hospital in Mumbai, Kokilaben Hospital offers cutting-edge oncology care and access to advanced global therapies.
  • Medanta – The Medicity: Medanta is a renowned super-specialty hospital where complex cancer cases are managed with advanced treatment protocols and global access support.
  • BLK-Max Super Speciality Hospital: BLK-Max provides comprehensive oncology services and supports patients seeking access to specialized treatment options.
  • Rajiv Gandhi Cancer Institute: A dedicated cancer care center, RGCI focuses on advanced oncology treatments and supports patients through complex treatment journeys.
  • HCG Cancer Centre: HCG is a specialized cancer hospital network known for its focus on precision oncology and advanced treatment modalities.
  • Narayana Health: Narayana Health combines affordability with advanced medical care, offering oncology services across multiple locations in India.
  • Amrita Hospital: Amrita Hospital provides high-quality cancer care with a focus on patient-centric treatment and access to modern therapies.
  • Yashoda Hospitals: Yashoda Hospitals are known for their strong oncology departments and advanced treatment infrastructure in South India.
  • Aster Hospitals: Aster Hospitals offer integrated cancer care services and support access to innovative therapies through coordinated treatment planning.
  • Sir Ganga Ram Hospital: A well-established hospital in Delhi, Sir Ganga Ram provides multidisciplinary cancer care supported by experienced specialists.
  • Jaslok Hospital: Jaslok Hospital is known for its specialized medical services and advanced oncology treatment capabilities.
  • Ruby Hall Clinic: Ruby Hall Clinic offers comprehensive cancer care and supports patients requiring advanced and imported therapies.
  • CARE Hospitals: CARE Hospitals provide modern oncology treatment facilities and multidisciplinary care across multiple cities.
  • Global Hospitals: Global Hospitals are equipped with advanced medical technologies and oncology expertise to manage complex cancer cases.

Note: Braftovi® is not stocked for direct purchase but is arranged through compliant import processes and delivered to the patient or hospital for patient-specific treatment.

Written By:

Nitin Goswami, Senior Medical Content Writer

Medically Reviewed By:

Shilpi Banerjee, Registered Pharmacist (M.Pharm)

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