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EPKINLY (Abbvie Pty Ltd)
Product name
EPKINLY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
178 (255 working days)
Active ingredients
epcoritamab
Registration type
NCE/ NBE
Indication
EPKINLY is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. EPKINLY is not indicated for the treatment of patients with primary central nervous system lymphoma.
This medicine has provisional approval in Australia for the treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic therapy. The decision to approve this indication has been made on the basis of overall response and duration of response from an uncontrolled, open label phase I/II study. Continued approval of this indication depends on verification and description of benefit in confirmatory trials.