Pfizer receives expanded Health Canada approval for Ibrance in HR+, HER2- metastatic breast cancer

New indication supported by results of Phase III PALOMA-3 Trial of Ibrance in combination with fulvestrant.

Pfizer Canada has announced that Health Canada has expanded the indication of Ibrance (palbociclib) to include its use in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy. Pre- or perimenopausal women must also be treated with a luteinizing hormone releasing hormone (LHRH) agonist.

"For patients with metastatic breast cancer, there is a pressing need for new and innovative treatment options," says Dr Sunil Verma, Oncologist and Head of the Department of Oncology, University of Calgary. "This expanded indication is important for patients and physicians, as this treatment approach may benefit those women living with advanced breast cancer."

"Women living with advanced breast cancer face unique challenges which can cause physical and emotional strain at a time when they're trying to maintain the best possible quality of life," says Cathy Ammendolea, Board Chair, Canadian Breast Cancer Network. "It's critical that advanced breast cancer patients have timely access to new innovative treatment options."

Ibrance is a protein kinase inhibitor, first granted conditional approval by Health Canada on 16 March 2016, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease. Pfizer Canada is currently working with provinces and territories to provide timely public funding of this innovative medication.

The Health Canada approval of this new expanded indication is based on the final results of the Phase III PALOMA-3 study in 521 patients including 39 Canadian patients in 11 sites. The trial studied whether Ibrance in combination with fulvestrant prolonged progression-free survival (PFS) compared with placebo plus fulvestrant in pre-, peri- and post-menopausal women with HR+, HER2- metastatic breast cancer whose disease progressed on or after prior endocrine therapy in the adjuvant or metastatic setting.

"Pfizer Canada is proud to support the breast cancer community and bring an important treatment option to even more women living with this disease," says John Leasure, Pfizer Oncology Canada Lead. "The expanded indication of Ibrance, the first CDK4/6 inhibitor approved in Canada, demonstrates our unwavering commitment to provide innovative medicines to patients that need them most."