Palbociclib

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Palbociclib.svg
Systematic (IUPAC) name
6-Acetyl-8-cyclopentyl-5-methyl-2-{[5-(1-piperazinyl)-2-pyridinyl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one
Clinical data
Trade names Ibrance
AHFS/Drugs.com entry
Legal status
Identifiers
CAS Number 571190-30-2
ATC code L01XE33 (WHO)
PubChem CID: 5330286
ChemSpider 4487437
ChEBI CHEBI:85993 YesY
ChEMBL CHEMBL189963
Synonyms PD-0332991
Chemical data
Formula C24H29N7O2
Molecular mass 447.533 g/mol
  • O=C2N(c1nc(ncc1/C(=C2/C(=O)C)C)Nc3ncc(cc3)N4CCNCC4)C5CCCC5
  • InChI=1S/C24H29N7O2/c1-15-19-14-27-24(28-20-8-7-18(13-26-20)30-11-9-25-10-12-30)29-22(19)31(17-5-3-4-6-17)23(33)21(15)16(2)32/h7-8,13-14,17,25H,3-6,9-12H2,1-2H3,(H,26,27,28,29)
  • Key:AHJRHEGDXFFMBM-UHFFFAOYSA-N

Palbociclib (codenamed PD-0332991, trade name Ibrance) is a drug for the treatment of ER-positive and HER2-negative breast cancer developed by Pfizer. It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6.[1][2]

Mechanism of action

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Further information: CDK inhibitor

Approvals and indications

The drug was reviewed and approved under the Food and Drug Administration’s (FDA) accelerated Priority Review and Breakthrough Therapy designation programs on February 3, 2015 as a treatment (in combination with letrozole) for patients with estrogen receptor positive advanced breast cancer.[3]

A potentially confirmatory phase 3 trial, PALOMA-2, was fully enrolled by Feb 2015.[4]

The PALOMA-2 trial reported positive results in April 2016.[5]

Clinical trials

The PALOMA-3 trial announced in April 2015 that the addition of palbociclib was superior to fulvestrant alone for progression-free survival.[6]

In the phase 2 PALOMA-1 trial reported at the April 2014 annual meeting of the American Association for Cancer Research, the addition of palbociclib to letrozole was shown to significantly slow the progression of advanced cancer (median progression-free survival increased from 10.2 months to 20.2 months), but was not shown to have a statistically significant effect on increasing patients' overall survival times.[7][8][9]

Pricing

Ibrance "can be ordered through select" specialty pharmacies and "sells for $9,850 for 30 days or $118,200 for a year's supply before discounts."[10] According to a statement by the New York-based Pfizer the price "is not the cost that most patients or payors pay" since most prescriptions are dispensed through health plans, which negotiate discounts for medicines or get government-mandated price concessions.[10] In the United States specialty pharmacies fill prescriptions for drugs that are usually high cost.[11][12]

References

  1. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  4. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  5. ↑ Late-stage study of expanded use of Pfizer's Ibrance successful; global regulatory applications to follow. April 2016
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ Breast Cancer Drug Shows ‘Groundbreaking’ Results By ANDREW POLLACK, APRIL 6, 2014
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ Palbociclib Shows Promising Results in Patients With Hormone Receptor-positive Metastatic Breast Cancer, AACR in the News, April 6, 2014
  10. ↑ 10.0 10.1 Lua error in package.lua at line 80: module 'strict' not found.
  11. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  12. ↑ Lua error in package.lua at line 80: module 'strict' not found.
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