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Lytgobi (futibatinib) is an oral, small-molecule kinase inhibitor that binds irreversibly to fibroblast growth factor receptors 1, 2, 3 and 4. FGFRs are receptor tyrosine kinases that regulate cell growth, survival, migration and differentiation. In certain bile duct cancers, an FGFR2 gene fusion or rearrangement leaves the FGFR2 kinase domain permanently switched on, driving tumour growth. Futibatinib blocks this abnormal signalling. Lytgobi is indicated for the treatment of:
In the European Union, the United Kingdom and Japan, the authorised indication covers locally advanced or metastatic cholangiocarcinoma (and, in Japan, unresectable biliary tract cancer) with an FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic therapy.
In the United States this indication was granted accelerated approval based on overall response rate and duration of response; continued approval may be contingent upon verification of clinical benefit in confirmatory trials. In the EU and UK the medicine holds a conditional marketing authorisation.
Approval was based on the pivotal Phase 2 FOENIX-CCA2 study (TAS-120-101), a global, open-label, single-arm trial in 103 patients with unresectable, locally advanced or metastatic iCCA harbouring FGFR2 rearrangements including fusions. Futibatinib 20 mg once daily produced an objective response rate of 42% (95% CI, 32–52) with a median duration of response of 9.7 months, and a 12-month overall survival rate of 72%.
Important: Lytgobi is a biomarker-directed therapy. Patients must have a documented FGFR2 gene fusion or other rearrangement, typically identified by next-generation sequencing (NGS) of tumour tissue. It is a prescription anticancer medicine and must be used under the supervision of a qualified medical oncologist.
The recommended dosage of Lytgobi is 20 mg taken orally once daily — administered as five 4 mg tablets, or as one 16 mg tablet plus one 4 mg tablet — continued until disease progression or unacceptable toxicity.
Lytgobi should be taken at approximately the same time each day, with or without food. Tablets must be swallowed whole and should not be chewed, crushed or dissolved. If a dose is missed or vomiting occurs, patients should follow the missed-dose instructions in the prescribing information and not take an additional dose to make up for it.
For adverse reactions, the dose may be interrupted, reduced in defined steps (for example to 16 mg once daily, then 12 mg once daily), or permanently discontinued as directed by the treating oncologist. No dose adjustment is required for mild hepatic impairment; use in moderate or severe hepatic impairment has not been studied. Concomitant use with strong CYP3A inhibitors or inducers, and with certain P-gp inhibitors, should be avoided.
Because hyperphosphataemia is expected with FGFR inhibition, patients are usually placed on a phosphate-restricted diet and may require phosphate-lowering therapy, with serum phosphate monitored throughout treatment.
This information is not a treatment plan. For personalized medical advice, consult your doctor and refer to the full prescribing information.
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 FGFR2 fusion/rearrangement 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.
You can manage the entire process seamlessly through the Named Patient Program App, available on both the Play Store and App Store.
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.
LYTGOBI (futibatinib) tablets may be imported in the patient's name only, by patients or government hospitals. The following documentation is required:
The order is confirmed only after receipt and verification of a valid prescription from the doctor and, if applicable, an import permit.
LYTGOBI (futibatinib tablets) is a prescription medicine that legally requires a doctor's prescription to be dispensed. As of current publicly available information, LYTGOBI is not commercially marketed or registered in India by the CDSCO.
However, patients in India can legally access LYTGOBI 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:
LYTGOBI 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.
NamedPatientProgram.com (NPP) can source Lytgobi 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, Lytgobi is shipped under GDP-compliant controlled room-temperature conditions with full batch traceability and tamper-evident packaging.
All prescriptions are dispensed and checked by registered pharmacists and dispatched from New Delhi, India, after legal requirements are fulfilled.
For Lytgobi cost in India and availability, contact NPP via WhatsApp at +91 98104 69557 | Toll-Free: 1800-1200-365 or email info@namedpatientprogram.com.
Named Patient Program supports access to Lytgobi for patients with FGFR2 fusion-positive cholangiocarcinoma across major cities in India, coordinating documentation, sourcing, and delivery with treating oncologists.
Patients in Mumbai can access Lytgobi through NPP with support from treating gastrointestinal oncologists at the city's leading cancer centers.
In Delhi, NPP coordinates with hospitals and specialty oncology clinics to facilitate timely access to Lytgobi for eligible patients.
Bangalore's oncology and molecular testing centers work with NPP to support patients requiring Lytgobi based on confirmed FGFR2 fusion or rearrangement status.
Patients in Chennai can access Lytgobi through NPP, with coordination between treating doctors and the program's regulatory and logistics team.
Hyderabad's oncology and genetic testing centers support diagnosis and access coordination for Lytgobi through NPP.
NPP facilitates access to Lytgobi for patients in Kolkata under the guidance of treating oncologists.
Patients in Pune can access Lytgobi through NPP with prescription-based coordination and delivery support.
NPP supports access to Lytgobi for patients in Ahmedabad, working directly with treating specialists.
Patients in Kochi and across Kerala can access Lytgobi through NPP's regulated import pathway.
NPP coordinates access to Lytgobi for patients in Chandigarh and the surrounding region.
Patients in Jaipur can access Lytgobi through NPP with support from treating oncologists.
NPP facilitates access to Lytgobi for patients in Lucknow and across Uttar Pradesh.
Patients in Bhubaneswar can access Lytgobi through NPP's coordinated import and delivery process.
NPP supports access to Lytgobi for patients in Guwahati and across the Northeast region.
NPP also supports access for patients in other Indian cities not listed above — contact the team to check availability and timelines for your location.
The generic name of Lytgobi is futibatinib.
Lytgobi is developed and manufactured by Taiho Pharmaceutical Co., Ltd. (marketed in the United States by Taiho Oncology, Inc. and in Europe by Taiho Oncology Europe GmbH).
Lytgobi is an oral kinase inhibitor. It binds irreversibly to fibroblast growth factor receptors 1, 2, 3 and 4, blocking the abnormal FGFR2 signalling that drives certain bile duct cancers.
Yes. The US FDA granted accelerated approval to Lytgobi on 30 September 2022 for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harbouring FGFR2 gene fusions or other rearrangements.
Lytgobi is approved in the United States, the European Union, Japan (approved June 2023 for unresectable biliary tract cancer harbouring FGFR2 gene fusions that has progressed after chemotherapy), and the United Kingdom (conditional marketing authorisation granted 4 September 2024, with a NICE recommendation issued on 11 September 2024), among other markets.
Lytgobi is supplied as white, round, film-coated tablets for oral use in 4 mg and 16 mg strengths, provided as a kit.
Commonly reported side effects include high blood phosphate levels (hyperphosphataemia), nail toxicity, musculoskeletal pain, constipation, diarrhoea, tiredness, dry mouth, hair thinning (alopecia), mouth sores (stomatitis), abdominal pain, dry skin, joint pain, taste changes, dry eye, nausea, reduced appetite, urinary tract infection, hand-foot syndrome (palmar-plantar erythrodysaesthesia) and vomiting. Serious reactions can include retinal pigment epithelial detachment. This is not a complete list — consult your doctor and the prescribing information.
Yes. Treatment requires documented evidence of an FGFR2 gene fusion or other rearrangement in the tumour, usually identified by next-generation sequencing. Your oncologist will arrange the required molecular testing.
Lytgobi import in India is possible through the Named Patient Program (NPP) — on behalf of an individual patient with a valid doctor's prescription and a confirmatory FGFR2 molecular report. NamedPatientProgram.com helps manage the process, including documentation, approvals, logistics, and delivery.
NamedPatientProgram.com facilitates compliant access to Lytgobi through verified manufacturers and qualified pharmaceutical supply channels for eligible patients.
Lytgobi is not commercially marketed in India, so pricing varies with sourcing, logistics, and regulatory factors. For the latest Lytgobi cost in India, call +91 96548 60915 or WhatsApp +91 98104 69557 or email info@namedpatientprogram.com.
Yes. Patients in SAARC countries (such as Nepal, Bangladesh, Sri Lanka, and others) and Gulf countries may access Lytgobi through patient-specific import provisions, depending on local regulations.
NamedPatientProgram.com acts as the Lytgobi importer in India, assisting with Named Patient Import processes, regulatory documentation, and compliant international procurement for patients requiring this therapy.
Yes, one can access Lytgobi in India through NamedPatientProgram.com, as this medicinal product is not yet registered or available in the country. We can help facilitate the import of Lytgobi tablets through authorized manufacturers and qualified pharmaceutical supply channels.
Store Lytgobi tablets at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F). Keep tablets in the original package, out of the reach of children. Refrigeration is not required.
Nitin Goswami
Senior Medical Content Writer
Shilpi Banerjee
Registered Pharmacist (M.Pharm)
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