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MARCH 2017 PBAC MEETING – ITEMS AWAITING TGA OUTCOMES DRUG NAME, FORM(S), STRENGTH(S), SPONSOR, TYPE OF SUBMISSION MIGALASTAT DRUG TYPE AND USE LISTING REQUESTED BY SPONSOR / PURPOSE OF SUBMISSION PBAC OUTCOME Fabry disease To request a Section 100 (Highly Specialised Drug Program) Authority Required listing for the treatment of Fabry disease. The PBAC recommendation cannot be made public until the TGA outcome is known. Hormone receptor positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer To request an Authority Required listing with a non-steroidal aromatase inhibitor (letrozole or anastrozole) as initial endocrine-based therapy in postmenopausal women with hormone receptor positive, HER2 negative advanced breast cancer. The PBAC recommendation cannot be made public until the TGA outcome is known. Capsule 150 mg Galafold® Amicus Therapeutics New listing (Major Submission) PALBOCICLIB Capsule 75 mg Capsule 100 mg Capsule 125 mg Ibrance® Pfizer Australia Pty Ltd New listing (Major submission)