The U.S. Food and Drug Administration has expanded the approved indication for Ibrance (palbociclib) now for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in women whose disease has progressed following endocrine therapy. Ibrance is an oral, cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor.
Ibrance had previously received the FDA's breakthrough therapy and priority review designations for this indication (OT 1/10/16 issue).
Ibrance has also previously been approved for use in combination with letrozole as a treatment for postmenopausal women with ER-positive, HER2-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease (OT 3/10/15 issue). This indication is approved under accelerated approval based on progression-free survival, and continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing confirmatory trial, PALOMA-2.
This new expanded approval for Ibrance is based on data from the Phase III PALOMA-3 trial of 521 women, regardless of menopausal status, who received either Ibrance plus fulvestrant or placebo plus fulvestrant (OT 8/10/15 issue). Women receiving the Ibrance-fulvestrant combination had a median progression-free survival of 9.5 months compared to 4.6 months for patients who received placebo plus fulvestrant. Duration of response was 9.3 months for the patients receiving the Ibrance combination, compared with 7.6 months for patients receiving the placebo combination.
The most common adverse events for patients receiving Ibrance plus fulvestrant were neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, thrombocytopenia, constipation, vomiting, alopecia, rash, decreased appetite, and pyrexia. The most frequently reported serious adverse events for patients receiving Ibrance plus fulvestrant were infections, pyrexia, neutropenia, and pulmonary embolism.
Ibrance is marketed by Pfizer Oncology.
Clinical Quick Facts
Drug: Ibrance (palbociclib)
Approved Indication: Treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant in women whose disease has progressed following endocrine therapy
Serious Side Effects: Infections, pyrexia, neutropenia, and pulmonary embolism
Common Side Effects: Neutropenia, leukopenia, infections, fatigue, nausea, anemia, stomatitis, headache, diarrhea, thrombocytopenia, constipation, vomiting, alopecia, rash, decreased appetite, and pyrexia