Posted by Michael Wonder on 22 Jun 2017
Pfizer receives expanded Health Canada approval for Ibrance
21 June 2017 - New indication supported by results of Phase 3 PALOMA-3 trial of Ibrance in combination with fulvestrant.
June 21, 2017 – Pfizer Canada 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 positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer whose disease progressed after prior endocrine therapy. Pre- or peri-menopausal women must also be treated with a luteinizing hormone releasing hormone agonist.
The Health Canada approval of this new expanded indication is based on the final results of the Phase 3 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 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.
