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news.Pfizer announced that the US Food and Drug Administration (FDA) has accepted for filing and granted Priority Review for a supplemental New Drug Application (sNDA) for Pfizer’s breast cancer medication, IBRANCE (palbociclib).
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If approved, the sNDA would expand the approved use of IBRANCE to reflect findings from the Phase 3 PALOMA-3 trial, which evaluated IBRANCE in combination with fulvestrant versus fulvestrant plus placebo in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy, including those with and without prior treatment for their metastatic disease.
The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 2016.
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 3 data set from the PALOMA-3 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 U.S. 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."
If Pfizer’s sNDA is approved, the updated IBRANCE label would comprise results from two metastatic breast cancer trials in which IBRANCE in combination with an endocrine therapy improved progression-free survival (PFS) compared to endocrine therapy alone, PALOMA-1 and PALOMA-3.
Based on the results of the PALOMA-1 trial, IBRANCE was approved by the FDA in February 2015 for use in combination with letrozole as a treatment for postmenopausal women with estrogen receptor-positive (ER+), HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
This indication is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial, PALOMA-2. The most frequently reported adverse event for IBRANCE plus letrozole in PALOMA-1 was neutropenia. For more information on the serious and most common side effects of IBRANCE plus letrozole, please see Important IBRANCE Safety Information at the end of this release.
The sNDA seeks to expand approved use of IBRANCE based on the PALOMA-3 trial results. PALOMA-3 enrolled 521 patients, 350 of whom received the combination of IBRANCE plus fulvestrant. Pfizer announced in April 2015 that the trial was stopped early due to efficacy based on an assessment by an independent Data Monitoring Committee (DMC).
The results were presented as a late-breaker at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) and were published in The New England Journal of Medicine in June 2015. The adverse events observed with IBRANCE in combination with fulvestrant in PALOMA-3 were generally consistent with their respective known adverse event profiles.
In November 2015, the combination of IBRANCE plus fulvestrant was added to the National Comprehensive Cancer Network Guidelines as a Category 1 recommendation for the treatment of 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.
About IBRANCE® (palbociclib)
IBRANCE is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6. CDKs 4 and 6 are key regulators of the cell cycle that trigger cellular progression.
IBRANCE is approved by the FDA for use in combination with letrozole as a treatment for postmenopausal women with ER+, HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
The effectiveness of IBRANCE in these patients is based on a study that measured PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase 3 trial, PALOMA-2, is fully enrolled. IBRANCE has also received regulatory approval in Albania, Chile and Macau.
In the European Union, the Marketing Authorization Application for IBRANCE, which is based on results from the PALOMA-1 and PALOMA-3 trials, is currently under review with the European Marketing Agency.