Subcutaneous formulation of daratumumab approved by the European Commission

On June 4, 2020, the subcutaneous formulation of daratumumab (dara) was granted marketing authorization by the European Commission for the treatment of adult patients with multiple myeloma (MM).¹

The new formulation is approved for all indications that were previously treated with intravenous dara, but with a fixed dose of 1,800 mg dara plus 30,000 units hyaluronidase administered subcutaneously into the abdomen over 3–5 minutes. The current indications of dara approved in Europe are:

• Adult patients with newly diagnosed MM ineligible for autologous stem cell transplant in combination with
  • lenalidomide + dexamethasone, or
  • bortezomib, melphalan, and prednisone
• Adult patients with newly diagnosed MM eligible for autologous stem cell transplant in combination with bortezomib, thalidomide, and dexamethasone
• Adult patients with MM who have received ≥ 1 prior therapy, in combination with
• • dexamethasone or
  • bortezomib and dexamethasone
• As a monotherapy for adult patients with relapsed and refractory MM, who have received
• • ≥ 1 proteasome inhibitor and ≥ 1 immunomodulatory agent, with progressive disease following most recent therapy

Review on the MM Hub the results leading to the approval of the subcutaneous dara from the COLUMBA trial and the PLEIADES trial. This approval promises to improve patient experiences of dara treatment across Europe, by reducing administration time whilst maintaining clinical activity and safety.

The MM Hub has been focusing on the ongoing potential of monoclonal antibodies in MM as an editorial theme, find more information on these agents discussed here.