Posted by Michael Wonder on 02 May 2020
Genmab announces U.S. FDA approval of subcutaneous formulation of daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj), for the treatment of patients with multiple myeloma
1 May 2020 - Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies.
Genmab announced today that the U.S. FDA has approved the use of the subcutaneous formulation of daratumumab, Darzalex Faspro (daratumumab and hyaluronidase-fihj).
Darzalex Faspro is approved for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.
