TRUQAP (AstraZeneca Pty Ltd)
Product name
TRUQAP
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
207 (255 working days)
Active ingredients
capivasertib
Registration type
NCE/NBE
Indication
TRUQAP is indicated in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0 or 1+, or IHC 2+/ISH-) locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen.