Taiho Oncology Bile Duct Cancer Drug OK’d

FDA has approved a Taiho Oncology NDA for Lytgobi (futibatinib) for treating adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic bile duct cancer (cholangiocarcinoma) harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements, which is determined using next-generation sequencing.

Approval was based on efficacy data from TAS-120-101 (NCT02052778), a single-arm trial that enrolled 103 patients. The data showed an overall response rate (ORR) of 42% and duration of response was 9.7 months, according to an FDA news release.

In terms of safety, the most common adverse reactions occurring in 20% or more of patients were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting, the agency says.