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Pralsetinib - Blueprint Medicines/Roche

Drug Profile

Pralsetinib - Blueprint Medicines/Roche

Alternative Names: BLU-667; CS 3009; Gavreto; Pratinib; RG 6396

Latest Information Update: 03 Dec 2020

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At a glance

  • Originator Blueprint Medicines
  • Developer Blueprint Medicines; CStone Pharmaceuticals
  • Class Amides; Amines; Antineoplastics; Cyclohexanes; Ethers; Fluorinated hydrocarbons; Pyrazoles; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Proto oncogene protein c ret inhibitors
  • Orphan Drug Status

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

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

Highest Development Phases

  • Marketed Non-small cell lung cancer
  • Registered Thyroid cancer
  • Phase I/II Solid tumours

Most Recent Events

  • 11 Jan 2021 Blueprint Medicines intends to receive approval and launch praseltinib in RET fusion-positive Non-small cell lung cancer in Europe in the first half of 2021
  • 11 Jan 2021 Blueprint Medicines plans to submit a Type II variation MAA to the EMA for pralsetinib for RET-altered thyroid cancers in the second half of 2021
  • 02 Dec 2020 Registered for Thyroid cancer (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adolescents, In adults) in USA (PO)
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