Pfizer’s Advanced Breast Cancer Drug Ibrance Approved for SaleMenu
The U.S. federal health regulators have given accelerated approval for Pfizer Inc.’s Ibrance to treat advanced breast cancer.
The U.S. Food and Drug Administration on Tuesday granted Ibrance accelerated approval, a type of temporary approval for diseases that don’t have viable treatment options based on less clinical data than required for traditional drug approvals.
Ibrance, which can be ordered through select specialty pharmacies, sells for US$9,850 for a month’s supply before discounts. Drug companies typically negotiate discounts with providers.
J.P. Morgan estimated the drug could generate US$4 billion in sales in 2020.
Ibrance, also known as palbociclib, is an experimental therapy that targets proteins in the body known as cyclin-dependent kinases, or CDKs, involved in the growth of cancer cells.
The accelerated approval was based on data from a study on 165 postmenopausal women with metastatic breast cancer classified as estrogen receptor-positive, human epidermal receptor 2-negative, who hadn’t received previous treatment for the advanced disease. The study found Ibrance stopped tumors from growing for a median of more than 20 months, about twice as long as the current treatment alone.
A late-stage clinical trial continues.
Ibrance is intended to be used with FDA-approved breast-cancer treatment letrozole.
The most common side effects included a decrease in infection-fighting white blood cells, fatigue, low red blood cell counts and low platelet counts.
The full prescribing information for IBRANCE can be found at www.IBRANCE.com.
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