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Scaled-Up Preparation of an Intermediate of Upatinib, ACT051-3
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Futibatinib: First Approval

Yahiya Y Syed1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|November 28, 2022
PubMed

Insights

Futibatinib (Lytgobi®) is a new targeted therapy for advanced bile duct cancer. This irreversible fibroblast growth factor receptor (FGFR) inhibitor received US approval in September 2022.

Area of Science:

  • Oncology
  • Pharmacology
  • Drug Development

Background:

  • Futibatinib is an oral, irreversible inhibitor targeting fibroblast growth factor receptors (FGFR) 1-4.
  • It is developed for various cancers, including cholangiocarcinoma, breast, gastric, urothelial, esophageal, and non-small cell lung cancer.

Purpose of the Study:

  • To summarize the development milestones of futibatinib.
  • To highlight the drug's journey leading to its first regulatory approval.

Main Methods:

  • Review of preclinical and clinical development data for futibatinib.
  • Analysis of regulatory submission and approval processes.

Main Results:

  • Futibatinib targets FGFR1-4 with covalent binding.
  • US FDA approval granted on September 30, 2022.
  • Indicated for previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with FGFR2 gene fusions or rearrangements.

Conclusions:

  • Futibatinib represents a significant advancement in targeted therapy for cholangiocarcinoma.
  • The development highlights successful progression from research to clinical application.

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