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Subcutaneous Daratumumab Receives FDA Approval
Posted: May 01, 2020
Subcutaneous Daratumumab Receives FDA Approval image

Today the US Food and Drug Administration (FDA) approved DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj, or a subcutaneous shot of daratumumab) for the treatment of multiple myeloma patients. This new, fixed-dose formula reduces treatment time from hours to minutes with similar impact as the longer IV administration. 

It was approved for both newly diagnosed (transplant inieligible) myeloma patients as well as relapsed/refractory myeloma patients. DARZALEX FASPRO™ is also approved with use in the following treatment combinations: 

  • With bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • With lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • For patients with relapsed or refractory multiple myeloma who have received at least one prior therapy
  • With bortezomib and dexamethasone in patients who have received at least 4 one prior therapy
  • By itself as a monotherapy
  • For 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.

The shot can be administered over 3-5 minutes. 

The FDA approval was based on the Phase III COUMBA study, which demonstrated that the subcutaneous version of daratumumab was similar in overall response rate and safety as the intravenous admnistration. As a bonus, this new admnistration also reduced infusion-related reactions by two-thirds compared to the IV version (from 34% to 13%). 

“Since the approval of daratumumab, a robust body of evidence has established its use as a treatment for multiple myeloma in both the frontline and relapsed and refractory settings,” said Saad Z. Usmani, M.D., Division Chief of Plasma Cell Disorders, Levine Cancer Institute. “With DARZALEX FASPRO there may be fewer administration-related reactions compared to intravenous DARZALEX, providing an additional treatment option that may help patients, oncologists and nursing staff.”

DARZALEX FASPRO™ will be available to patients and physicians as soon as the week of May 11, 2020. The intravenous DARZALEX® formulation will also remain available as an option for patients and their physicians.

For financial help using daratumumab, patients can use the Janssen CarePath Program. Through the program, eligible commercial patients pay no more than $5 per injection, regardless of individual income level. Information on the enrollment process is available online at For more information, healthcare providers or patients can contact: 1-844-55DARZA (1- 844-553-2792).

It's exciting to see new therapies and more convenient options for myeloma patients become FDA-approved! 


The author Jennifer Ahlstrom

about the author
Jennifer Ahlstrom

Myeloma survivor, patient advocate, wife, mom of 6. Believer that patients can contribute to cures by joining HealthTree Cure Hub and joining clinical research. Founder and CEO of HealthTree Foundation. 

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