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Palbociclib : ウィキペディア英語版
Palbociclib

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.
The drug IBRANCE 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.〔(【引用サイトリンク】 FDA Approves Palbociclib for Metastatic Breast Cancer )〕 A potentially confirmatory phase 3 trial, PALOMA-2, has fully enrolled patients.〔(【引用サイトリンク】 Pfizer Receives U.S. FDA Accelerated Approval of IBRANCE® (palbociclib) )〕 The PALOMA-3 trial announced in April 2015 that the addition of palbociclib was superior to fulvestrant alone for progression-free survival.
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.〔(Breast Cancer Drug Shows ‘Groundbreaking’ Results ) By ANDREW POLLACK, APRIL 6, 2014〕〔(Palbociclib Shows Promising Results in Patients With Hormone Receptor-positive Metastatic Breast Cancer ), AACR in the News, April 6, 2014〕
==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." 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.〔 In the United States specialty pharmacies fill prescriptions for drugs that are usually high cost.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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