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.”

Lytgobi (futibatinib)

General Description

Lytgobi (futibatinib) is a kinase inhibitor approved for the treatment of adult patients with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma that harbors FGFR2 (fibroblast growth factor receptor 2) gene fusions or other rearrangements. The U.S. FDA granted its approval on September 22, 2022.

Getting Lytgobi (futibatinib) in India

Lytgobi (futibatinib)is approved in the U.S., Europe, and other countries, but it is not yet commercially available in India. However, eligible patients in India may access this important therapy through the Named Patient Program (NPP).

MitoGENE helps patients obtain Lytgobi (futibatinib) legally and safely, in collaboration with their treating doctor. We assist with documentation, import coordination, and delivery—ensuring full compliance with Indian regulatory guidelines.

If you or a loved one needs Lytgobi (futibatinib), MitoGENE is here to guide you through every step of the process.

Disease Indications:Bile Duct Cancer

Manufacturer:Taiho Pharmaceuticals

Usage:Oral

Medicine Approved by:

  • European Medical Agency (EMA)
  • Food and Drug Administration (FDA)
  • Pharmaceuticals and Medical Devices Agency (PMDA)

Available Dosage Form & Package:

  • 35 tablets x 4 mg (7-day supply for 20 mg/day

Shipping:

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

What is LYTGOBI (futibatinib)?

LYTGOBI is a prescription medicine used to treat adults with a type of bile duct cancer called intrahepatic cholangiocarcinoma that has spread (metastatic) or cannot be removed by surgery. It is intended for patients who have already received previous treatment and whose tumors have an abnormal FGFR2 (fibroblast growth factor receptor 2) gene.

Before starting LYTGOBI, your healthcare provider will perform a test to confirm whether your cancer has this specific FGFR2 gene alteration.

LYTGOBI has not been established as safe or effective for use in children.

This medicine received accelerated FDA approval based on tumor shrinkage and the duration of response. Ongoing studies are underway to confirm whether LYTGOBI helps patients live longer or improves symptoms.

Important Safety Information

Possible Serious Side Effects Include:

1. Eye Problems:
Common but potentially serious. These include:

2. High Phosphate Levels in the Blood (Hyperphosphatemia):
This can lead to calcium and mineral buildup in tissues. Your doctor will monitor your phosphate levels and may:

  • Common Side Effects Include:
    • Changes in kidney or liver function tests
    • High blood sugar
    • Low red and white blood cell counts
    • Nail problems or color changes
    • Muscle pain, joint pain
    • Fatigue or weakness
    • Constipation or diarrhea
    • Dry mouth, dry skin, dry eyes
    • Mouth sores, abdominal pain
    • Hair loss
    • Nausea, vomiting, loss of appetite
    • Taste changes
    • Urinary tract infections
    • Hand-foot syndrome (redness, swelling, or tenderness on palms/soles)
    • This is not a complete list. Speak to your doctor or pharmacist for a full overview. You may also report side effects to the FDA at 1-800-FDA-1088.

Before Taking LYTGOBI, Tell Your Doctor If You:

  • Have vision or eye issues
  • Are pregnant or plan to become pregnant

LYTGOBI may harm your unborn baby or cause a miscarriage

A pregnancy test is required before starting treatment

Women should use effective birth control during treatment and for 1 week after the last dose

Men should use birth control with partners who can become pregnant during treatment and for 1 week after

Are breastfeeding or plan to breastfeed

Do not breastfeed during treatment or for 1 week after the last dose

Take any prescription, over-the-counter medications, vitamins, or herbal supplements

LYTGOBI may interact with other medications

  • Diarrhea
  • Constipation
  • Low platelet count (thrombocytopenia)
  • Peripheral neuropathy
  • Nausea or vomiting
  • Swelling (peripheral edema)
  • Back pain

Serious side effects include:

  • Severe thrombocytopenia
  • Severe diarrhea

References

Clinical Study FOENIX-CCA2: Futibatinib in Patients With FGFR2-altered iCCA
ClinicalTrials.gov Identifier: NCT02052778, Taiho Oncology, Updated 2023
https://clinicaltrials.gov/ct2/show/NCT02052778

Prescribing Information: Lytgobi (futibatinib) [PDF]
Taiho Oncology, U.S. FDA, Sep 2022
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215196s000lbl.pdf

Lytgobi (futibatinib) Receives Accelerated Approval from the U.S. FDA to Treat Intrahepatic Cholangiocarcinoma, FDA Press Release
U.S. Food and Drug Administration, Sep 2022
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-futibatinib-intrahepatic-cholangiocarcinoma

Patient Information: Lytgobi (futibatinib)
Taiho Oncology, Sep 2022
https://www.lytgobi.com

Full Prescribing Information: Lytgobi (futibatinib) [PDF]
Taiho Oncology, Sep 2022
https://www.taihooncology.com/us/assets/files/prescribing_info/LYTGOBI-PI.pdf

Four Simple Steps to AccessLytgobi (futibatinib)

If Lytgobi (futibatinib)is not yet approved or available commercially in your country, MitoGENE can help you access it through a legal pathway. Here’s how:

    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.