FDA Approves Palbociclib Plus Fulvestrant for Metastatic Breast Cancer (UPDATED)

Palbociclib now available to broader range of women
Breast Cancer News
March 7, 2016
Erin Rowley, Writer and Content Coordinator
Reviewed By: 
Kathy D. Miller, MD

On Feb. 19, the FDAinfo-icon announced it approved palbociclib (Ibrance) in combination with fulvestrantinfo-icon (Faslodexinfo-icon) for women with estrogen receptor-positiveinfo-icon, HER2-negative metastaticinfo-icon breast cancer who experienced the disease growing or spreading despite hormonal therapyinfo-icon treatment.

The approval comes after the release of results from the phase III PALOMA-3 trial, which looked at giving palbociclib and fulvestrant together. Living Beyond Breast Cancer called those results “possibly practice-changing” when they were reported at last year’s American Society of Clinicalinfo-icon Oncologyinfo-icon (ASCO) meeting, in Chicago, and published in the New England Journal of Medicine.

Background and Reason for Approval

In February 2015, the FDA approved the targeted therapyinfo-icon palbociclib for postmenopausalinfo-icon women with estrogen receptor-positive, HER2-negative metastatic breast cancer who hadn't been treated with hormonal therapy for metastatic breast cancer before, in combination with letrozoleinfo-icon (Femarainfo-icon). Letrozole is a kind of hormonal therapy called an aromatase inhibitorinfo-icon. Palbociclib was the first cyclin-dependent kinase (CDK) 4/6 inhibitor to be approved by the FDA. CDK 4/6 inhibitors target two specific kinases, or enzymes, that help tumorinfo-icon cells grow and divide.

FDA approval usually comes after a phase III trialinfo-icon, but palbociclib was granted accelerated approval because of exciting phase II trialinfo-icon results that suggested it could double progression-free survivalinfo-icon (PFS), the time between starting treatment and the disease growing or spreading.

The PALOMA-3 trial looked at whether palbociclib would be effective when used with fulvestrant, a hormonal therapy medicineinfo-icon used to treat metastatic breast cancer, for women whose metastatic breast cancer progressed after hormonal therapy treatment. Women who hadn't yet gone through menopauseinfo-icon were able to participate in the trial, as long as they were taking an LHRH agonist to stop their ovaries from working.

PALOMA-3 found that with palbociclib and fulvestrant, it took more than twice as long (9.5 months) for disease to progress than with a placeboinfo-icon and fulvestrant (4.6 months).

What This Means For You

You may have been interested in palbociclib for metastatic breast cancer but unable to take it because the disease had already progressed after hormonal therapy treatment or because you aren't postmenopausal. But now, this medicine may be an option for you. Talk to your oncologistinfo-icon about whether treatment with palbociclib plus fulvestrant could be right for you.

Keep in mind that this treatment does have side effects. The majority of PALOMA-3 participants handled palbociclib plus fulvestrant well, but most of them did experience low blood counts, which can cause infectioninfo-icon, abnormalinfo-icon bleeding and extreme tiredness. Other side effects were experienced less often, but were still common. They include:


This article was updated with additional information March 21, 2016.

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