LYTGOBI 12MG/ 20MG (FUTIBATINIB)

What is Lytgobi?

Lytgobi (futibatinib) belongs to a class of medications called kinase inhibitors. Futibatinib works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.  Lytgobi is used in adults to treat bile duct cancer (cholangiocarcinoma) that has spread (metastatic) or cannot be removed by surgery:

• who have already received another treatment; and
• whose tumor has an abnormal “FGFR2” gene

📌 General Information

• Brand Name: LYTGOBI

• Generic Name: Futibatinib

• Drug Class: Irreversible FGFR1–4 tyrosine kinase inhibitor

• Manufacturer: Taiho Oncology / Taiho Pharmaceuticals

🏥 Approved Use

• For adults with previously treated, unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) harboring FGFR2 gene fusions or rearrangements

• Received accelerated FDA approval on September 30, 2022, based on Phase II data. Also approved in Japan (June 2023) and Europe (July 2023)

💊 Dosage & Administration

• Recommended Dose: 20 mg orally once daily, until disease progression or unacceptable toxicity

• Dose Reduction Guidelines: First reduction to 16 mg daily, then to 12 mg daily; discontinue if 12 mg not tolerated

• Administration: With or without food, taken at the same time each day. Swallow whole — do not crush or chew

🔬 Efficacy

• Based on the FOENIX‑CCA2 Phase II trial:

  • Objective response rate (ORR): 42%

  • Median duration of response: 9.7 months

  • Disease control rate: 83%

  • Median time to response: 2.6 months .

⚠️ Safety Profile

Common Adverse Effects

• Diarrhea, fatigue, dry mouth, constipation, vomiting, nail disorders, musculoskeletal pain, dry skin, alopecia, stomatitis, arthralgia, dysgeusia, abdominal pain, UTI

Notable Warnings

• Ocular toxicity: Retinal pigment epithelial detachment in ~9%. Baseline ophthalmic exam + OCT every 2 months for 6 months, then every 3 months taihooncology.com.

• Serious toxicity: Hepatic, renal, electrolyte imbalances; monitor regularly via labs .

🔍 Regulatory Reminder

• In early 2025, the FDA flagged misleading efficacy claims on LYTGOBI’s HCP website, noting that single-arm phase II data cannot meaningfully support PFS/OS statements

🇮🇳 Availability in India

• Import via Named Patient Supply: Companies like Indian Pharma Network (IPN) and Medvitaz Pharma can facilitate importation through Form 12A/12B channels

• Access process: Requires FGFR2‑fusion positive test, oncologist prescription, and procedure documentation. Targeted for cities nationwide, including Indore.

✅ Summary

LYTGOBI (futibatinib) is the first irreversible FGFR inhibitor for advanced FGFR2-positive iCCA. It offers significant response rates (≈42%) and decent duration of response (~9–10 months). While generally well-tolerated, it requires regular monitoring for eye, liver, and metabolic issues, and adherence to dose modifications. Patients and physicians should be informed about ongoing regulatory considerations and careful interpretation of efficacy claims.