LOUISVILLE, Ky.--(BUSINESS WIRE)--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 rearranagements. 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
About Onco360 Oncology Pharmacy:
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
- 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
- LYTGOBI_Prescribing_Information.pdf (amazonaws.com). accessed on 10/24/2022.