The Food and Drug Administration (FDA) has approved Darzalex Faspro™ (daratumumab and hyaluronidase-fihj; Janssen) for the treatment of newly diagnosed or relapsed/refractory multiple myeloma in adult patients.

Darzalex Faspro is a new subcutaneous (SC) formulation that contains daratumumab, a CD38-directed cytolytic antibody, with hyaluronidase, an endoglycosidase. The new SC formulation is administered over approximately 3 to 5 minutes compared with the intravenous (IV) formulation of daratumumab (Darzalex®) that is administered over hours. Darzalex Faspro is indicated 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. 
  • In combination with lenalidomide and dexamethasone 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 monotherapy, in patients who have received at least 3 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 approval was based on data from the phase 3 COLUMBA and the phase 2 PLEIADES studies. The open-label, noninferiority COLUMBA study evaluated the efficacy and safety of Darzalex Faspro monotherapy in 522 patients with refractory or relapsed multiple myeloma. Patients were randomized to receive either Darzalex Faspro (1800mg/30,000 units) SC or daratumumab 16mg/kg IV once weekly until unacceptable toxicity or disease progression. Results showed that Darzalex Faspro achieved noninferiority with an ORR of 41.1% compared with 37.1% for daratumumab (risk ratio [RR] 1.11; 95% CI, 0.89-1.37). The geometric mean ratio comparing Darzalex Faspro to daratumumab IV for maximum Ctrough was 108% (90% CI, 96-122).

Additionally, the multicenter, single-arm, phase 2 PLEIADES study assessed the efficacy and safety of Darzalex Faspro in combination with bortezomib, melphalan and prednisone in 67 patients with newly diagnosed multiple myeloma who were ineligible for transplant. Findings from this group of patients showed an ORR of 88.1% (95% CI, 77.8-94.7). Moreover, in PLEIADES, the combination of Darzalex Faspro with lenalidomide and dexamethasone was evaluated in 65 patients who had received at least 1 prior line of therapy. Results from this group showed an ORR of 90.8% (95% CI, 81.0-96.5).

With regard to safety, Darzalex Faspro demonstrated a similar profile to that observed with intravenous daratumumab. Moreover, treatment with Darzalex Faspro was associated with a significant reduction in systemic administration-related reactions compared with intravenous daratumumab (13% vs 34%, respectively). 

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“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, MD, 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 is expected to be available the week of May 11, 2020 in single-dose vials containing 1800mg daratumumab and 30,000 units hyaluronidase per 15mL. To prevent medication errors, the vial labels should be checked to ensure that the drug being prepared and administered is for subcutaneous use; Darzalex Faspro should not be administered intravenously.

The Company will also offer a copay savings card to assist patients. 

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