U.S. FDA approves Pfizer's high profile breast cancer drug

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http://www.reuters.com/article/2015/02/03/us-pfize...


U.S. FDA approves Pfizer's high profile breast cancer drug

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  • JohnSmith
    JohnSmith Member Posts: 651
    edited April 2015

    I imagine others are discussing this in various portions of the forum, but in a nutshell, the FDA granted accelerated approval to Pfizer's palbociclib (Ibrance) [a CDK inhibitor], a pill for use in patients with MBC. When given in combination with letrozole (Femara), the new drug extends progression-free survival in post-menopausal patients with Stage 4 estrogen-receptor (ER) positive, Her2 negative (ER+/Her2-) tumors.
    In a randomized trial, Palbociclib nearly doubled progression-free survival in women with metastatic breast cancer, from 10.2 to 20.2 months.

    The drug was approved based on results of an open (non-blinded) Pfizer-sponsored phase 2 trial called PALOMA-1. The results look at two patient cohorts with median follow-up of 27-30 months. The 165 patients, all postmenopausal women with stage 4, ER+/Her2- breast cancer, enrolled between Dec 2009 and May 2012. The women were randomized to receive either letrozole (an AI) alone or in combination with palbociclib, taken once daily for 21 days out of every 28.

    Roughly 13% dropped out of the study, likely due to toxicity issues (the article didn't specifically cite why they dropped out).

  • JohnSmith
    JohnSmith Member Posts: 651
    edited March 2016

    Approved Pfizer breast cancer drug (Ibrance) impresses in latest Phase 3 study "Paloma 3"

    Pfizer said today the first formal late-stage trial of its approved treatment for advanced breast cancer, Ibrance, was stopped early after the medicine met its goal of delaying progression of the disease in previously treated patients.

    The Phase III study, called Paloma 3, was halted after an independent data monitoring board determined that Ibrance, also known as palbociclib, had proven its effectiveness among patients with advanced disease who had previously been treated with anti-estrogen drugs.

  • Alli_FLA
    Alli_FLA Member Posts: 84
    edited April 2015

    I'll be starting this soon. I picked it up yesterday and it cost a little over $12,000.00. I have coverage so didn't pay anything. I have to get a specific shot before starting. That's for my case, not really part of program.

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