The CD38-directed monoclonal antibody daratumumab (Darzalex) has been listed by the TGA for the treatment of patients with refractory or relapsed multiple myeloma. The immunotherapy is the first in its class to receive a listing in Australia.
It has been approved by the TGA for use:
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and
- as monotherapy for the treatment of patients who have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent.
Manufacturer Janssen Australia says it is now working to provide the PBAC with a submission that will support its recommendation on the PBS.
“Our priority is to ensure patients living with this complex blood cancer have affordable long-term access to Darzalex and we will work constructively with the PBAC and Federal Government to secure this outcome,” said Janssen Australia Managing Director, Bruce Goodwin.
For product information on Darzalex PI (1) click on the link.