DARZALEX (Janssen-Cilag Pty Ltd)

The approved indications for DARZALEX are:

DARZALEX is 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 ineligible for autologous stem cell transplant. For use in combination with:
• • bortezomib, melphalan and prednisone, or
  • lenalidomide and dexamethasone.
• with relapsed or refractory multiple myeloma who have received:
• at least one prior therapy. For use in combination with:
• bortezomib and dexamethasone, or
• lenalidomide and dexamethasone.
• carfilzomib 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.

The approved indications for DARZALEX SC are:

DARZALEX SC is 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 ineligible for autologous stem cell transplant. For use in combination with:
• bortezomib, melphalan and prednisone, or
• lenalidomide and dexamethasone.
• with relapsed or refractory multiple myeloma who have received:
• at least one prior therapy. For use in combination with:
• bortezomib and dexamethasone, or
• lenalidomide and dexamethasone, or
• carfilzomib and dexamethasone, or
• pomalidomide and dexamethasone (after at least one prior therapy including lenalidomide and a proteasome inhibitor (PI)).
• at least three prior lines of therapy including a PI and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent. For use as:
  • monotherapy.

DARZALEX SC in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain AL amyloidosis.