ZYNLONTA (Swedish Orphan Biovitrum Pty Ltd)
Product name
ZYNLONTA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
164 (255 working days)
Active ingredients
loncastuximab tesirine
Registration type
NCE/NBE
Indication
ZYNLONTA monotherapy is provisionally approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
ZYNLONTA is not indicated for patients with primary central nervous system lymphoma.
The decision to approve this indication has been granted on the results from an openlabel, uncontrolled Phase 2 study based on the overall response rate. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.
First generic
First approval of a medicine that contains the same active ingredient as and is bioequivalent to an existing medicine