The Therapeutic Goods Administration (TGA) Approved PEMAZYRE (Pemigatinib)

Summary:

• Australia has authorised the use of a new targeted therapy for the treatment of cholangiocarcinoma, a rare bile duct cancer. The Therapeutic Goods Administration (TGA) has granted PEMAZYRE (pemigatinib) provisional approval for the treatment of adult patients with metastatic or locally advanced cholangiocarcinoma who also have a fusion or rearrangement of the fibroblast growth factor receptor 2 (FGFR2) that has progressed following at least one line of systemic therapy.

The overall response rate (ORR) and response length have been taken into consideration while deciding whether to accept this indication. The confirmation and characterization of benefit in confirmatory trials are necessary for this indication’s continued approval.

This implies that it will be accessible to Australian patients with cholangiocarcinoma who have undergone testing to determine whether their tumours include an aberrant gene change known as a FGFR2 fusion or rearrangement, a flaw that can fuel the development of cancer. Approximately 15% of cholangiocarcinoma patients are thought to have this abnormality.

About PEMAZYRE

• API– Pemigatinib
• Description -Pemazyre is a cancer medicine used to treat adults with cholangiocarcinoma (biliary tract cancer or cancer of the bile ducts) when the cancer cells have an abnormal form of a receptor (target) called FGFR2 on their surface. Pemazyre is used when the cancer has spread to other parts of the body or cannot be removed by surgery and has worsened after previous treatment with at least one cancer medicine. PEMAZYRE is a drug belonging to the kinase inhibitor class that was developed by US-based Incyte and licenced to individual pharmaceutical company Specialised Therapeutics (ST) in Singapore for commercialization in Australia, New Zealand, and Singapore, inhibits the unusual FGFR2 protein in bile duct tumour cells to stop cell growth.
• Mechanism of Action -The API in Pemazyre, pemigatinib, belongs to a group of medicines called protein kinase inhibitors. It works by blocking the activity of receptors called fibroblast growth factor receptors (FGFRs). Abnormal FGFRs are found on the surface of cancer cells and are involved in the growth and spread of the cancer. By blocking their activity, Pemazyre reduces the growth and spread of the cancer.

• Class –Antineoplastics; Ethers; Fluorobenzenes; Morpholines; Pyridines; Pyrimidinones; Pyrroles; Small molecules
• Indication-Cholangiocarcinoma

About Therapeutic Goods Administration (TGA)

The Therapeutic Goods Administration is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics. The TGA has obligations under the Protective Security Policy Framework to ensure it develops, documents, implements and reviews appropriate security measures to protect information from unauthorised use or accidental modification, loss or release.

Weblink: https://www.chemrobotics.com

• AgroPat Lite– Access 5500 pesticides with chemistry, Biology, Regulatory, and IP info. Covers the product information including formulation, combination, developer, innovator, existing intellectual property, regulatory requirement, biology data including spectrum, MOA, DFU, toxicity profile, and safety. (Designed for Business Development function)
  • • • Weblink: https://www.chemrobotics.com/agropat-lighter/
    • AgroPat Ultimate– In detailed Access 5500 pesticides with chemistry, Biology, Regulatory, and IP info. (Designed for Research & Development function)
      • Weblink: https://www.chemrobotics.com/agropat-ultimate/
    • Indian Medicine Database –Approved Drugs, Medical Devices, Approved Regenerative Medical Products
      • Weblink: https://imd.chemrobotics.com/
    • Indian Pesticide Database (IPD)– All Indian Approvals, e.g. 9(3) and 9(4), etc.
      • Weblink: https://www.chemrobotics.com/agropat-lighter/ipd
    • Global Agro Product Directory(More than 55countries approved product info. with relevant documents such as label, factsheet and monograph)
    • Weblink: https://www.chemrobotics.com/pesticides-directory/
  • Global MRL Database(More than 85 countries MRL info.)
    • Weblink: https://www.chemrobotics.com/agrochem/mrl-database
  • Jarvis– A Competitor Patents Watch Database for Agrochemical
    • Weblink: https://www.chemrobotics.com/agrochem/agro-patent
  • Technical Routes(More than 15000 routes of synthesis for Agrochemical & Pharmaceutical)
    • Weblink: https://www.chemrobotics.com/agrochem/technical-routes
  • Technical Suppliers(Provides technical supplier information)
    • Weblink: https://www.chemrobotics.com/agrochem/technical-supplier
  • Company Directory– KSM Supplier(s) Database — More than 10 K Companies listed from Pharma / Agrochemical / Fine Chemical Domain with their product offering in Pharma / Agrochemical / Fine Chemical segment,
    • Weblink: https://companydirectory.chemrobotics.com
  • ChemRobotics SPC Database– Provides Patent SPC data Europe
    • Weblink: https://chemrobotics.com/agropharm/#/spcdb
  • PharmVetPat –Access chemistry including ROS, KSM, Intermediate, Biology, Regulatory, and IP info for all pharm molecules.
• Weblink: https://chemroboticspharma.com/pharmVetPat