FOR IMMEDIATE RELEASE:
Lytgobi® (futibatinib) Now Available from Onco360 for the Treatment of Adult Patients with Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma Harboring FGFR2 Gene Fusions or Other Rearrangements
Louisville, KY — Onco360®, the nation’s leading independent Specialty Pharmacy, has been selected by Taiho Oncology to be a specialty pharmacy partner for Lytgobi® (futibatinib), which is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
“Onco360 is honored to partner with Taiho Oncology and become a specialty pharmacy provider for Lytgobi patients,” said Benito Fernandez, Chief Commercial Officer, Onco360. “We are committed to supporting the highly specialized needs of patients battling treatment-experienced, FGFR2-mutant, advanced cholangiocarcinoma patients across the United States.”
According to the American Cancer Society (ACS), it is estimated that 8,000 patients will be diagnosed with cholangiocarcinoma annually. The five-year overall survival (OS) for cholangiocarcinoma, regardless of stage, is only 9%. With regard to cholangiocarcinoma patients with distant metastatic disease, the five-year OS is only 2%.1 Approximately 20% of cholangiocarcinoma cases are considered intrahepatic in terms of tumor location.2 10-16% of intrahepatic cholangiocarcinoma cases have FGFR2 mutations.3
Lytgobi is developed and commercialized by Taiho Oncology. The FDA approval of Lytgobi comes as a result of the Phase I/II, open-label, single-arm TAS-120-101 (NCT02052778) clinical trial which evaluated the use of Lytgobi in previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma patients. The TAS-120-101 demonstrated that Lytgobi administration resulted in a 42% overall response rate (ORR) in 103 study participants.4
- All statistics from https://www.cancer.org/cancer/bile-duct-cancer/about/key-statistics.html#:~:text=Bile%20duct%20cancer%20(cholangiocarcinoma)%20is,diagnosed%20with%20it%20each%20year. Accessed on 10/24/2022
- Valle JW et al. Biliary Tract Cancer. Lancet. 2021;397:428-444
- FDA Approves Taiho’s LYTGOBI® (futibatinib) Tablets for Previously Treated, Unresectable, Locally Advanced or Metastatic Intrahepatic Cholangiocarcinoma (prnewswire.com). accessed on 10/24/2022
- pdf (amazonaws.com). Accessed on 10/24/2022.
Benito Fernandez, Chief Commercial Officer