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Osimertinib - AstraZeneca

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Drug Profile

Osimertinib - AstraZeneca

Alternative Names: [11C]AZD9291; [11C]osimertinib; ADAURA; AZD-9291; Mereletinib; TAGRISSO; Tagrisso

Latest Information Update: 10 Jun 2025

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At a glance

  • Originator AstraZeneca
  • Developer AstraZeneca; Avistone Pharmaceuticals; Dana-Farber Cancer Institute; Eli Lilly and Company; European Organisation for Research and Treatment of Cancer; European Thoracic Oncology Platform; G1 Therapeutics; Genprex; HUTCHMED; Incyte Corporation; Kyushu University; Molecular Partners AG; National Cancer Institute (USA); National University Hospital (Singapore); Princess Margaret Hospital (University of Toronto); Singapore Clinical Research Institute; Sunnybrook Health Sciences Centre; University of California at San Francisco
  • Class Acrylamides; Amides; Aniline compounds; Antineoplastics; Dimethylamines; Indoles; Phenyl ethers; Pyrimidines; Small molecules
  • Mechanism of Action Epidermal 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 - Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase III Cancer; Meningeal carcinomatosis; Solid tumours
  • Phase II Adenocarcinoma; Glioblastoma

Most Recent Events

  • 02 Jun 2025 Efficacy and adverse event data from a phase III SACHI trial in Non-small cell lung cancer released by HUTCHMED
  • 21 May 2025 Registered for Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease) in Canada (PO)
  • 25 Mar 2025 Updated efficacy and adverse event data from a phase II ORCHARD trial in Non-small cell lung cancer released by AstraZeneca

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