Product Dossier
APLIDIN
Product Dossier for APLIDIN (plitidepsin, Specialised Therapeutics Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Specialised Therapeutics Pharma
- Active ingredient: plitidepsin
- Therapeutic area: Oncology
- Same area: TALZENNA
- Same area: ZARZIO
What it is
Aplidin is plitidepsin 2 mg powder for solution for infusion.
Approved indications
— Aplidin, 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.
Key safety warnings
The drug has a favourable haematological safety profile, which could be beneficial for patients with limited marrow reserve or comorbidities.
Regulatory history
Aplidin was first listed on the ARTG on 12 December 2018. The TGA approved Aplidin, in combination with dexamethasone, for the treatment of patients with relapsed and refractory multiple myeloma on 10 December 2018, allowing its use after specific prior treatment regimens. The approval considered the unmet clinical need for new treatment options with a distinct mechanism of action.