FDA approval allows for subcutaneous dosing of daratumumab for myeloma
The FDA approved daratumumab and hyaluronidase-fihj for adults with newly diagnosed or relapsed/refractory multiple myeloma.
The approval of this product allows for subcutaneous dosing of daratumumab (Darzalex, Janssen).
Daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) is approved for several indications for which IV daratumumab is already authorized.
These include:
in combination with bortezomib (Velcade, Millennium/Takeda), melphalan and prednisone for newly diagnosed patients who are ineligible for autologous stem cell transplant;
in combination with lenalidomide (Revlimid, Celgene) and dexamethasone for newly diagnosed patients who are ineligible for autologous stem cell transplant and for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy;
in combination with bortezomib and dexamethasone for patients who received at least one prior therapy; and
as monotherapy for patients who received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.
The recommended dose of daratumumab and hyaluronidase-fihj is 1,800 mg daratumumab and 30,000 units hyaluronidase administered subcutaneously into the abdomen over approximately 3 minutes to 5 minutes.