ELAHERE (Abbvie Pty Ltd)
Product name
ELAHERE
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
144 (175 working days)
Active ingredients
mirvetuximab soravtansine
Registration type
NCE/NBE
Indication
ELAHERE as monotherapy is indicated for the treatment of adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens (see Section 4.2).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.