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Palbociclib - Onyx Pharmaceuticals/Pfizer

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Drug Profile

Palbociclib - Onyx Pharmaceuticals/Pfizer

Alternative Names: IBRANCE; Ibrance; Iburance; Parvociclib; PD-0332991; PD-332991; PD-991; PF-332991

Latest Information Update: 28 Jul 2025

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At a glance

  • Originator Onyx Pharmaceuticals; Pfizer; SOLTI Breast Cancer Research Group
  • Developer Assistance Publique Hopitaux de Paris; Bergonie Institute; Calithera Biosciences; Canadian Cancer Trials Group; Celgene Corporation; Dana-Farber Cancer Institute; Emory University; European Organisation for Research and Treatment of Cancer; Georgetown University; German Breast Group; Grupo Espanol de Tumores Neuroendocrinos; GSK; International Breast Cancer Study Group; iOMEDICO AG; Karolinska Institute; National Cancer Institute (USA); Northwestern University; Pfizer; UNC Lineberger Comprehensive Cancer Center; UNICANCER; University of California at San Francisco; University of Texas M. D. Anderson Cancer Center; Washington University School of Medicine
  • Class 2 ring heterocyclic compounds; Antineoplastics; Cyclopentanes; Ketones; Piperazines; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase III HER2 negative breast cancer
  • Phase II/III Non-small cell lung cancer
  • Phase II Adenocarcinoma; Bone metastases; Brain metastases; Gastrointestinal stromal tumours; Mantle-cell lymphoma; Pancreatic cancer; Prostate cancer; Squamous cell cancer; Urogenital cancer
  • Phase I/II Colorectal cancer; Malignant melanoma
  • No development reported Acute myeloid leukaemia; Glioblastoma; Multiple myeloma; Precursor cell lymphoblastic leukaemia-lymphoma; Solid tumours
  • Discontinued Astrocytoma; Glioma

Most Recent Events

  • 28 Jul 2025 No recent reports of development identified for phase-I development in Colorectal-cancer(Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (PO, Capsule)
  • 30 May 2025 Pharmacodynamics data from the phase II ImmunoADAPT trial in Breast cancer presented at the 61st Annual Meeting of the American Society of Clinical Oncology (ASCO-2025)
  • 13 Jan 2025 Updated results from the phase III PENELOPE-B trial in Breast cancer presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)

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