Futibatinib is under clinical development by Otsuka Pharmaceutical and currently in Phase II for Solid Tumor. According to GlobalData, Phase II drugs for Solid Tumor have a 10% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Futibatinib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Futibatinib overview

Futibatinib (Lytgobi) is an anticancer agent. It is formulated as a film-coated tablet for oral route of administration, Lytgobi is 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.

TAS-120 (futibatinib) is under development for the treatment of solid tumors including advanced or metastatic urothelial carcinoma, cholangiocarcinoma (CCA), unspecified cancer (FGFR aberrations cancer), non-small-cell lung cancer, HER2-negative metastatic breast cancer, HR positive metastatic breast cancer and triple-negative breast cancer, breast cancer, glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, urothelial carcinoma, metastatic gastric cancer, gastro esophageal junction cancer, metastatic hepatocellular carcinoma, metastatic microsatellite stable endometrial carcinoma, multiple myeloma, myeloid and lymphoid neoplasms. The drug candidate is administered orally. It is a small molecule acts by targeting fibroblast growth factor receptors (FGFRs).

It was also under development for squamous cell lung cancer harboring FGFR1 gene amplification.

Otsuka Pharmaceutical overview

Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment. The company develops formulations for diagnosis and treatment of central nervous system, oncology, cardiovascular and renal, gastrointestinal, ophthalmology disorders and infectious diseases through its pharmaceutical business. It’s nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. OPC is investigating drugs for psychiatry and neurology; oncology; cardiovascular and other therapeutic indications in collaboration with academia and venture companies. The company operates branch offices, research facilities and factories in Japan. OPC is headquartered in Chiyoda-ku, Tokyo, Japan.

For a complete picture of Futibatinib’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.