The US Food and Drug Administration (FDA) has granted priority review and accepted for filing for a supplemental new drug application (sNDA) for Pfizer’s Ibrance (palbociclib), designed to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer.
If approved, the sNDA would expand the use of Ibrance to reflect findings from the Phase III Paloma-III trial, which evaluated the drug in combination with fulvestrant versus fulvestrant plus placebo in these women.
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The trial evaluated the combination in women, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target of April 2016 for a decision by the agency.
Pfizer Oncology global president and general manager Liz Barrett said: "We look forward to continuing to work with the FDA to add the robust Phase III data set from the Paloma-III trial to the available data in the Ibrance label.
"Since FDA approval in February, more than 18,000 women have been treated with Ibrance by approximately 5,000 prescribers in the US. With approval of this indication, we hope to expand the role of Ibrance in combination with endocrine therapy for the treatment of HR+, HER2- metastatic breast cancer and to serve even more patients with this first-in-class medicine."
The company said that following approval, the updated Ibrance label would comprise results from two metastatic breast cancer trials Paloma-I and Paloma-III, with used Ibrance in combination with an endocrine therapy improved progression-free survival (PFS) compared to endocrine therapy alone.
In February, the FDA approved Ibrance based on the Paloma-I trial data for use in combination with letrozole to treat postmenopausal women with estrogen receptor-positive (ER+), HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
The sNDA seeks to expand approved use of the drug based on the results from the Paloma-III trial, which included 521 patients, with 350 of these receiving the combination of Ibrance plus fulvestrant.
In November, the combination of Ibrance plus fulvestrant was added to the National Comprehensive Cancer Network Guidelines as a Category 1 recommendation to treat women with HR+, HER2- metastatic breast cancer who have progressed on endocrine therapy, or premenopausal women receiving ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist.
