FDA Approves Expanded Breast Cancer Indication for Ibrance

The approval was based on data from the Phase 3 PALOMA-3 trial
The approval was based on data from the Phase 3 PALOMA-3 trial

Pfizer announced that the Food and Drug Administration (FDA) has expanded the indication for Ibrance (palbociclib) capsules for use in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.

The FDA's approval was based on data from the Phase 3 PALOMA-3 trial in pre-, peri-, and post-menopausal women with HR+, HER2- metastatic breast cancer with disease progression on or after prior endocrine therapy in the adjuvant or metastatic setting. 

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In PALOMA-3 (n=521), patients were randomized 2:1 to receive Ibrance + fulvestrant or placebo + fulvestrant. The data showed Ibrance + fulvestrant prolonged progression-free survival (PFS) vs. placebo + fulvestrant in women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy. Patients in the Ibrance + fulvestrant arm had a median PFS of 9.5 months (95% CI: 9.2, 11.0) vs. 4.6 months (95% CI: 3.5, 5.6) in the placebo + fulvestrant group (HR 0.461, 95% CI: 0.360, 0.591; P<0.0001).

Ibrance, a cyclin-dependent kinase 4/6 inhibitor, is already approved for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women.

Ibrance is available as 75mg and 125mg strength capsules.

For more information visit Ibrance.com.

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