FDA Approves Lytgobi For Treatment Of Intrahepatic Cholangiocarcinoma With FGFR2 Gene Abnormalities
The U.S. Food and Drug Administration (FDA) has approved a novel targeted drug, Lytgobi (Futibatinib), for the treatment of unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma (iCCA) patients.
This approval provides a new treatment option for patients who have received at least one prior line of systemic therapy and still have progressive disease.
Mechanism Of Action Of Lytgobi
Lytgobi is a highly selective and irreversible FGFR1-4 inhibitor that inhibits tumor cell proliferation by blocking the aberrant activation of the FGFR signaling pathway through covalent binding to the ATP-binding site of the FGFR protein.
Unlike other FGFR inhibitors, Lytgobi’s mechanism of action allows for stronger targeting and longer-lasting inhibition, reducing the development of drug resistance.
Key Clinical Trial Data
The approval is based on the results of the FOENIX-CCA2 Phase II clinical trial, which enrolled 103 patients with intrahepatic cholangiocarcinoma harboring abnormalities in the FGFR2 gene.
The study showed an objective remission rate (ORR) of 42%, meaning that nearly half of the patients experienced significant tumor shrinkage.
The median duration of remission (DOR) was 9.7 months, with 72% of patients in remission for more than 6 months.
Common adverse reactions included nail toxicity, musculoskeletal pain, constipation, and diarrhea but were well tolerated overall.
Current Status of Treatment For Intrahepatic Cholangiocarcinoma
Intrahepatic cholangiocarcinoma is a malignant tumor with high aggressiveness and poor prognosis, accounting for about 20% of cholangiocarcinomas.
Due to the insidious early symptoms, most patients are in advanced stage at the time of diagnosis and lose the chance of surgery.
Traditional chemotherapy regimens have limited effects, with a 5-year survival rate of less than 10%.
The incidence of FGFR2 gene abnormality in intrahepatic cholangiocarcinoma patients is about 10-16%, and the approval of Lytgobi brings the possibility of precision treatment to this specific population.
Future Research Directions
Currently, Taiho Pharmaceutical, Lytgobi’s development company, is exploring its use in combination with other targeted drugs or immunotherapies.
For example, a clinical trial in combination with Boundless Bio’s CHK1 inhibitor BBI-355 is advancing, aiming to overcome the problem of drug resistance.
In addition, scientists are investigating the potential of FGFR inhibitors in other FGFR-dependent tumors (e.g., gastric cancer, breast cancer, etc.).
Conclusion
The approval of Lytgobi marks the entry of intrahepatic cholangiocarcinoma treatment into the era of precision medicine, providing new hope for patients with abnormalities in the FGFR2 gene.
In the future, with the development of more combination therapies, the treatment landscape of this refractory cancer may further improve.
About DengYueMed – HK Drug Wholesale Distributor
As a legally compliant drug import and export company, DengYueMed is certified by the pharmacy & poisons board of Hong Kong — you can verify our qualification on their official website.
Our efforts to improve the affordability of Futibatinib drug aim to ensure that more patients can benefit from this important medication.
HK DengYue provides detailed medicine information, transparent pricing, and responsive support to ensure a smooth and reliable buying experience.
Feel free to reach out anytime to discuss your needs or ask questions about the medicine. We welcome you to contact us for a consultation.
