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Bemarituzumab - Amgen

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Drug Profile

Bemarituzumab - Amgen

Alternative Names: AMG-552; Anti-FGFR2b antibody - Five Prime Therapeutics; FPA-144

Latest Information Update: 08 Aug 2024

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At a glance

  • Originator Galaxy Biotech
  • Developer Amgen; Five Prime Therapeutics; ZAI Lab
  • Class Antineoplastics; Immunotherapies; Monoclonal antibodies
  • Mechanism of Action Type-2 fibroblast growth factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Adenocarcinoma
  • Phase I/II Solid tumours
  • Phase I Gastric cancer; Non-small cell lung cancer

Most Recent Events

  • 06 Aug 2024 Zai Lab completes enrolment in the phase III FORTITUDE-101 trial for Adenocarcinoma (Combination therapy, First-line therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in South Africa, Turkey, Thailand, Taiwan, Spain, Sweden, Singapore, Romania, Portugal, Poland, Peru, Norway, Mexico, Malaysia, Latvia, Japan, South Korea, Italy, Israel, Ireland, Greece, France, Estonia, Denmark, Czech Republic, Colombia, China, Chile, Canada, Bulgaria, Brazil, Australia, Argentina (IV) (NCT05052801) (EudraCT2021-003461-35)
  • 28 May 2024 Amgen completes a phase I trial in Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Monotherapy) in USA, Spain, Poland, Japan, Belgium, France, Taiwan and South Korea (IV) (NCT05267470)
  • 08 Feb 2024 Phase-I/II clinical trials in Solid tumours (Inoperable/Unresectable, Second-line therapy or greater, Late-stage disease, Metastatic disease) in Argentina, Brazil, Finland, Italy, Romania (IV) (NCT05325866)

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