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FDA grants priority review to Ibrance for new indication in advanced breast cancer
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The FDA granted priority review to a supplemental new drug application for the breast cancer medication palbociclib.
Palbociclib (Ibrance, Pfizer) — an oral agent that inhibits cyclin-dependent kinases (CDK) 4 and 6 — already is approved for use in combination with letrozole for treatment of postmenopausal women with ER-positive, HER-2–negative advanced breast cancer as initial endocrine-based therapy for metastatic disease.
The supplemental application requests that the approval be expanded to allow for use of palbociclib in combination with fulvestrant in women with hormone receptor-positive, HER-2–negative metastatic breast cancer that progressed after endocrine therapy. The application requests approval in this setting regardless of patients’ menopausal status or receipt of prior treatment for metastatic disease.
The application is based on results of the PALOMA-3 study, which showed the addition of palbociclib to fulvestrant (Faslodex, AstraZeneca) more than doubled the duration of disease control in women with hormone receptor-positive, HER-2–negative advanced breast cancer who progressed on endocrine therapy (median PFS, 9.2 months vs. 3.8 months; HR = 0.42; 95% CI, 0.32-0.56).
“Since FDA approval in February, more than 18,000 women have been treated with Ibrance by approximately 5,000 prescribers in the U.S.,” Elizabeth Barrett, global president and general manager of Pfizer Oncology, said in a press release. “With approval of this indication, we hope to expand the role of Ibrance in combination with endocrine therapy for the treatment of HR-positive, HER-2–negative advanced breast cancer and to serve even more patients.”
The FDA is expected to make a decision on the supplemental application by April.