DARZALEX, JANSSEN DARATUMUMAB (Janssen-Cilag Pty Ltd)
Product name
DARZALEX, JANSSEN DARATUMUMAB
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
186 working days (255)
Active ingredients
daratumumab
Registration type
EOI
Indication
DARZALEX (concentrated solution for injection) is now also indicated for the treatment of patients:
- with newly diagnosed multiple myeloma:
- who are eligible for autologous stem cell transplant. For use in combination with:
- bortezomib, thalidomide, and dexamethasone.
- who are eligible for autologous stem cell transplant. For use in combination with:
- who are ineligible for autologous stem cell transplant. For use in combination with:
- bortezomib, melphalan and prednisone, or
- lenalidomide and dexamethasone.
- with multiple myeloma who have received:
- at least one prior therapy. For use in combination with:
- bortezomib and dexamethasone, or
- lenalidomide and dexamethasone.
- at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as:
- monotherapy.
- at least one prior therapy. For use in combination with: