SARCLISA (Sanofi-Aventis Australia Pty Ltd)
Product name
SARCLISA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
166 working days (255)
Active ingredients
isatuximab
Registration type
NCE/NBE
Indication
SARCLISA (concentrated solution for injection) is indicated in combination with pomalidomide and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least two prior therapies including lenalidomide and a proteasome inhibitor (PI).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.