Palbociclib

Drug Profile

Palbociclib

Alternative Names: Ibrance; PD-0332991; PD-332991; PD-991; PF-332991

Latest Information Update: 20 Jan 2017

Price : $50

At a glance

  • Originator Onyx Pharmaceuticals; Pfizer
  • Developer Assistance Publique Hopitaux de Paris; Dana-Farber Cancer Institute; Georgetown University; German Breast Group; GlaxoSmithKline; iOMEDICO AG; Karolinska Institute; Merck & Co; National Cancer Institute (USA); Northwestern University; Pfizer; UNC Lineberger Comprehensive Cancer Center; University of California at San Francisco
  • 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase II/III Non-small cell lung cancer
  • Phase II Brain metastases; Head and neck cancer; Urogenital cancer
  • Phase I/II Cancer; Malignant melanoma
  • Phase I Colorectal cancer; Mantle-cell lymphoma; Pancreatic cancer; Solid tumours
  • No development reported Glioblastoma; Multiple myeloma

Most Recent Events

  • 21 Dec 2016 PDUFA action date of April 2017 assigned by the US FDA for sNDA for regular approval of pablociclib in Brest cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, First line therapy)
  • 21 Dec 2016 Pfizer submits sNDA for regular approval of palbociclib in Breast cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, First line therapy) (PO) in USA before December 2016
  • 21 Dec 2016 The US FDA assigns Priority Review status to sNDA for regular approval of palbociclib in Breast cancer (Combination therapy, Late-stage disease, Inoperable/Unresectable, First line therapy) in USA (PO)
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