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# Pfizer Reports Favorable Ibrance Breast Cancer Data
- URL: https://www.fdaweb.com/pfizer-reports-favorable-ibrance-breast-cancer-data/
- Published: 2024-12-12T12:00:00.000Z
- Updated: 2026-09-14T14:49:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158362

Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC).

In the study, median PFS was 44.3 months for patients treated with Ibrance in combination with anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) and endocrine therapy, and 29.1 months for patients treated with anti-HER2 therapy and endocrine therapy alone, according to the company. “Overall survival, a secondary endpoint, was not yet mature at the time of the analysis,” it says. “These results support the potential of this maintenance treatment to slow disease progression and improve clinical outcomes in this patient population.”

During the study, Ibrance’s safety and tolerability was consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative MBC, and no new safety signals were documents, Pfizer says. “The most common adverse events observed with Ibrance were hematologic toxicities, such as neutropenia and leukopenia,” it says, adding that non-hematologic adverse events included fatigue, stomatitis and diarrhea.

Ibrance is currently approved for treating adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men. It is also approved for use fulvestrant in patients with disease progression following endocrine therapy.