Saad Z. Usmani, on the Approval of Daratumumab and Hyaluronidase-fihj

May 18, 2020

The hematologist and medical oncologist discussed the approval of daratumumab and hyaluronidase-fihj for use in adult patients with newly diagnosed or relapsed/refractory multiple myeloma.

In an interview with CancerNetwork®, Saad Z. Usmani, MD, FACP, hematologist and medical oncologist at Levine Cancer Institute, spoke about the recent approval of daratumumab and hyaluronidase-fihj (Darzalex Faspro) for use in adult patients with newly diagnosed or relapsed/refractory multiple myeloma. 

The addition of this product now allows for subcutaneous dosing of daratumumab.

“One of the concerns that medical oncologists have had is the long infusion time [of daratumumab], especially in the first cycle of treatment,” said Usmani. “The subcutaneous formulation of daratumumab brings a lot of convenience to the patients.” 

The combination of daratumumab and hyaluronidase-fihj is now approved for the following indications, of which intravenous daratumumab had already received approval:

  • In combination with bortezomib (Velcade), melphalan (Evomela), and prednisone (Rayos) (VMP) in newly diagnosed patients who are ineligible for autologous stem cell transplant.

  • In combination with lenalidomide (Revlimid) and dexamethasone (Ozurdex) (Rd) in newly diagnosed patients who are ineligible for autologous stem cell transplant and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy.

  • In combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy.

  • As a monotherapy in patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent.

“[This] is going to be very important moving forward in the new COVID-19 pandemic environment where we’re trying to find innovative ways in which we can streamline the operations in the clinic, as well as make things more convenient for our patients and do it in a safe environment,” Usmani said. 

References:

FDA. FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma. FDA website. Published May 1, 2020. fda.gov/drugs/drug-approvals-and-databases/fda-approves-daratumumab-and-hyaluronidase-fihj-multiple-myeloma. Accessed May 1, 2020. 

This segment comes from the CancerNetwork® portion of the MJH Life Sciences National Broadcast, airing daily on all MJH Life Sciences channels.