KYPROLIS (Amgen Australia Pty Ltd)
Product name
KYPROLIS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
230 (255 working days)
Active ingredients
carfilzomib
Registration type
EOI
Indication
Kyprolis is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy as part of combination therapy with:
- dexamethasone, or
- lenalidomide and dexamethasone, or
- daratumumab and dexamethasone, or
- isatuximab and dexamethasone
Registration process
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine