APLIDIN (Specialised Therapeutics Pharma Pty Ltd)
Product name
APLIDIN
Date registered
Evaluation commenced
Decision date
Approval time
239 working days (255)
Active ingredients
plitidepsin
Registration type
NCE/NBE
Indication
APLIDIN (powder for solution for infusion), in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least three prior treatment regimens, including both a proteasome inhibitor and an immunomodulator. APLIDIN may be used after two prior lines of therapy if refractory and/or intolerant to both a proteasome inhibitor and an immunomodulator.