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FDA expands approval of Ibrance for advanced breast cancer
The FDA approved a supplemental new drug application for use of palbociclib as initial endocrine therapy for postmenopausal women with hormone receptor–positive, HER-2–negative advanced or metastatic breast cancer.
The FDA previously granted accelerated approval for the use of palbociclib (Ibrance, Pfizer) — a cyclin dependent kinase (CDK) 4/6 inhibitor — in combination with letrozole.
The FDA action converts that accelerated approval to regular approval, and also expands the indication to include use of palbociclib in combination with an aromatase inhibitor for the same indication.
“In the 2 years since its initial approval, Ibrance has been prescribed to more than 50,000 patients by more than 9,800 physicians in the United States,” Liz Barrett, global president and general manager of Pfizer Oncology, said in a company-issued press release. “This important update to the Ibrance label underscores the strength of the data we continue to generate for Ibrance. We are proud of the impact this innovative medicine continues to have on patients’ lives.”
The FDA based its actions on results of the confirmatory phase 3 trial PALOMA-2 trial, designed to evaluate the addition of palbociclib to letrozole as first-line therapy for postmenopausal women with ER–positive, HER-2–negative metastatic breast cancer.
Women who received palbociclib plus letrozole achieved significantly longer PFS than those who received placebo plus letrozole (24.8 months vs. 14.5 months; HR = 0.58; 95% CI, 0.46-0.72).
Researchers observed no new safety signals.
The most common grade 3/grade 4 adverse reactions among women assigned the combination were neutropenia (66% vs. 2%), leukopenia (25% vs. 0%), infections (7% vs. 3%) and anemia (5% vs. 2%).
In 2016, the FDA granted regular approval to the use of palbociclib in combination with fulvestrant (Faslodex, AstraZeneca) for the treatment of women with hormone receptor–positive, HER2–negative advanced or metastatic breast cancer whose disease progressed following endocrine therapy.