free survival (PFS) benefit observed in PALOMA-1 study. Continued approval for this indication is contingent upon verification and description of clinical benefit in PALOMA-2 study. Submitted 29 November 2016 For the treatment of hormone receptor (HR) HER2 negative advanced or metastatic breast cancer: -in combination with an aromatase inhibitor as initial endocrine- based therapy in postmenopausal women Singapore Approved 21 July 2016 Ibrance in combination with letrozole for the treatment of postmenopausal women with ER+, advanced breast cancer as initial endocrine-based therapy for their metastatic disease Switzerland Approved 31 January 2017 Ibrance is indicated for the treatment of hormone receptor (HR)-positive, trial epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with fulvestrant in pre-/peri- (combined with LHRH analogs) or postmenopausal women who have received prior endocrine therapy Submission First quarter 2017 Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with letrozole in pre-/peri- (combined with LHRH analogs) or postmenopausal women New Zealand Under Abbreviated NMA ref. Ibrance is indicated for the evaluation EU consent submitted treatment of hormone receptor (granted Full 31 October 2016 (HR)-positive, human epidermal Priority growth factor receptor 2 Review) locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy.
free survival (PFS) benefit observed in PALOMA-1 study. Continued approval for this indication is contingent upon verification and description of clinical benefit in PALOMA-2 study. Submitted 29 November 2016 For the treatment of hormone receptor (HR) HER2 negative advanced or metastatic breast cancer: -in combination with an aromatase inhibitor as initial endocrine- based therapy in postmenopausal women Singapore Approved 21 July 2016 Ibrance in combination with letrozole for the treatment of postmenopausal women with ER+, advanced breast cancer as initial endocrine-based therapy for their metastatic disease Switzerland Approved 31 January 2017 Ibrance is indicated for the treatment of hormone receptor (HR)-positive, epidermal growth factor receptor 2 advanced or metastatic breast cancer in combination with fulvestrant in pre-/peri- (combined with LHRH analogs) or postmenopausal women who have received prior endocrine therapy Submission First quarter 2017 Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 advanced or metastatic breast cancer in combination with letrozole in pre-/peri- (combined with LHRH analogs) or postmenopausal women New Zealand Under evaluation (granted Full Priority Review) Abbreviated NMA ref. EU consent submitted 31 October 2016 Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 locally advanced or metastatic breast cancer: in combination with an aromatase inhibitor; in combination with fulvestrant in women who have received prior endocrine therapy. trial negative negative
auspar-palbociclib-180430.docx