The U.S. Food and Drug Administration (FDA) has approved a new subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj or Darzalex Faspro) for five indications in multiple myeloma patients.

Daratumumab and hyaluronidase-fihj can be administered subcutaneously in  three to five minutes—significantly quicker than the hours needed to deliver the  intravenous formulation.

The five indications the new formulation is approved for include:

  • in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant
  • 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
  • as monotherapy, in patients who have 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 approval was largely based on data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies.

In the COLUMBA study, the overall response rate (ORR) was non-inferior for patients taking daratumumab and hyaluronidase-fihj as monotherapy compared to those taking intravenous daratumumab as monotherapy (41%  vs. 37%, respectively). In addition, there were fewer systemic administration-related reactions with daratumumab and hyaluronidase-fihj versus intravenous daratumumab 13% vs. 34%, respectively). In the Phase 2 PLEIADES study, daratumumab and hyaluronidase-fihj in combination therapies for a variety of patient populations was found to be safe and effective.

In a news release, Saad Z. Usmani, MD, Division Chief of Plasma Cell Disorders, Levine Cancer Institute said, “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.”

Dr. Usmani added “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.”

Multiple myeloma is a rare blood cancer in which malignant growth of plasma cells in the bone marrow. Individuals with multiple myeloma develop significant osteolytic bone lesions and have immunodeficiency that compromise their longevity and quality of life.

It  is estimated that 32,270 people will be diagnosed with multiple myeloma in the US and 12,830 will die from the disease. Treatment is often individualized based on the patient’s age, general health, symptoms, disease severity, etc, but often will involve a combination of modalities (chemotherapy, pain management, radiation therapy, stem cell therapy).


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