Drug Profile

Palbociclib - Onyx Pharmaceuticals/Pfizer

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

Latest Information Update: 13 Jan 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

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

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)
12 Dec 2024 Adverse events and efficacy data from a phase III PATINA trial in Breast cancer released by Pfizer
10 Dec 2024 Efficacy and adverse events data from phase III AFT-38 PATINA trial in Breast cancer presented at the 47th Annual San Antonio Breast Cancer Symposium (SABCS-2024)

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