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Sotorasib - Amgen

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Drug Profile

Sotorasib - Amgen

Alternative Names: AMG-510; LUMAKRAS; LUMYKRAS

Latest Information Update: 23 Aug 2024

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At a glance

  • Originator Amgen; Carmot Therapeutics
  • Developer Amgen; BeiGene; REVOLUTION Medicines; Verastem Oncology
  • Class Antineoplastics; Piperazines; Pyridines; Pyridones; Pyrimidines; Small molecules
  • Mechanism of Action KRAS protein inhibitors
  • Orphan Drug Status

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

    Yes - Colorectal cancer; Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Phase III Colorectal cancer; Solid tumours
  • Phase I/II Brain metastases; Pancreatic cancer

Most Recent Events

  • 07 Aug 2024 Sotorasib receives priority review status for Colorectal cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO)
  • 06 Aug 2024 US FDA assigns PDUFA action date of (17/10/2024) for sotorasib for Colorectal cancer
  • 31 May 2024 Efficacy and adverse events data from phase II SCARLET trial for Non-small cell lung cancer presented at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO-2024)

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