Taiho Oncology was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) for Lytgobi^® (futibatinib) tablets on Sept. 30, 2022. It is indicated for adults who have already received other treatment for advanced forms of intrahepatic cholangiocarcinoma that test positive for gene abnormalities in growth factor receptor 2 (FGFR2) and that cannot be surgically removed. The recommended daily dose is 20mg (five tablets) taken all at once. Cost, distribution, and launch plans are not yet known. Look here for prescribing information.

At a Glance

• Brand (Generic) Name: Lytgobi (futibatinib)
• Manufacturer: Taiho Oncology
• Date Approved: Sept. 30, 2022
• Indication: treatment of adult patients who have previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements
• Dosage Forms Available: 4mg oral tablets
• Launch Date: The launch date isn’t known at this time.
• Estimated Annual Cost: Pricing information is not currently available.
• Intrahepatic cholangiocarcinoma is a fast-spreading cancer of the bile ducts inside the liver. The five-year survival rate for metastatic cases is less than 10%.
• An estimated 1,600 patients are diagnosed with intrahepatic cholangiocarcinoma each year in the United States. Up to 16% of them have FGFR2 abnormalities.
• Lytgobi blocks FGFR2 to interfere with cancer cell stability and spread.
• In the open-label clinical trial that led to the approval, 43 of the 103 patients showed some response to treatment with Lytgobi. Response time averaged 9.7 months.
• At least one-fifth of study participants experienced dry eyes, mouth and/or skin; fingernail and toenail damage; gastrointestinal disturbances; muscle and/or joint pain; pain and swelling in the hands and/or feet; urinary tract infections; and other side effects from taking Lytgobi.
• At the beginning of treatment and every few months during therapy, patients using it should have detailed eye exams due to the potential for retinal detachment. Blood levels of phosphate also should be checked on a regular basis since Lytgobi could increase them, possibly resulting in adverse effects on soft tissues and blood vessels.
• Pemazyre^® (pemigatinib – Incyte Pharmaceuticals) and Truseltiq^® (infigratinib – BridgeBio Pharma/Helsinn Group) are other targeted drugs currently FDA approved for treating adults who have FGFR2 rearranged cholangiocarcinoma that has been treated previously, but that has spread locally or metastasized and that cannot be removed surgically.
• Because the approval was accelerated, positive results from continuing clinical studies will be needed before the FDA fully approves Lytgobi. A designated Orphan Drug and Breakthrough Therapy, it was given Priority Review and considered under the Real-Time Oncology Review (RTOR) pilot pathway.