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Tucatinib - Array BioPharma/Seagen

Drug Profile

Tucatinib - Array BioPharma/Seagen

Alternative Names: ARRY 380; Irbinitinib; MK 7119; ONT 380; TUKYSA

Latest Information Update: 10 Nov 2022

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At a glance

  • Originator Array BioPharma
  • Developer Array BioPharma; Criterium; Merck & Co; Merck Sharp & Dohme; Novartis; Seagen
  • Class 2 ring heterocyclic compounds; Antineoplastics; Diamines; Oxazoles; Pyridines; Quinazolines; Small molecules; Triazoles
  • Mechanism of Action ERBB 2 receptor antagonists; Phosphorylation inhibitors
  • Orphan Drug Status

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

    Yes - Colorectal cancer; Breast cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed HER2 positive breast cancer
  • Preregistration Colorectal cancer
  • Phase II/III Gastrointestinal cancer
  • Phase II Biliary cancer; Bladder cancer; Cervical cancer; Endometrial cancer; Non-small cell lung cancer; Solid tumours
  • Phase I Cholangiocarcinoma; Gallbladder cancer; Gastric cancer

Most Recent Events

  • 21 Sep 2022 Planned Prescription Drug User Fee Act (PDUFA) date for Colorectal cancer (Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in USA (PO) is 2023-01-19
  • 19 Sep 2022 Tucatinib receives priority review status for Colorectal cancer (Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in USA
  • 01 Sep 2022 Preregistration for Colorectal cancer (Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line therapy or greater) in USA (PO)
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