Daratumumab/hyaluronidase

Daratumumab/hyaluronidase, sold under the brand name Darzalex Faspro, is a combination drug for the treatment of adults with newly diagnosed or relapsed/refractory multiple myeloma.[1][2] It is a combination of daratumumab and hyaluronidase.[2] It is administered via subcutaneous injection.[2]

Daratumumab/hyaluronidase
Combination of
DaratumumabCD38-directed cytolytic antibody
HyaluronidaseEndoglycosidase
Clinical data
Trade namesDarzalex Faspro
License data
Routes of
administration		Subcutaneous
ATC code
  • none
Legal status
Legal status

The most common adverse reaction using daratumumab/hyaluronidase as monotherapy is upper respiratory tracts infection.[2]

Medical uses

Daratumumab/hyaluronidase is indicated for the treatment of adults with multiple myeloma:[1]

  • in combination with bortezomib, melphalan and prednisone (D-VMP) in newly diagnosed adults who are ineligible for autologous stem cell transplant[2][1]
  • in combination with lenalidomide and dexamethasone (D-Rd) in newly diagnosed adults who are ineligible for autologous stem cell transplant and in people with relapsed or refractory multiple myeloma who have received at least one prior therapy[2][1]
  • in combination with bortezomib and dexamethasone (D-Vd) in adults who have received at least one prior therapy[2][1]
  • as monotherapy, in adults 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.[2][1]

History

It was approved for use in the United States in May 2020.[1][3][4]

Efficacy of daratumumab and hyaluronidase-fihji (monotherapy) was evaluated in the COLUMBA trial (NCT03277105), an open-label non-inferiority trial randomizing 263 participants to daratumumab and hyaluronidase-fihj and 259 to intravenous daratumumab (daratumumab IV).[1] The trial's co-primary endpoints were overall response rate (ORR) and pharmacokinetic (PK) endpoint of the maximum Ctrough on cycle 3, day 1 pre-dose.[1] Daratumumab and hyaluronidase-fihj was non-inferior to daratumumab IV in evaluating these two endpoints.[1]

Efficacy of daratumumab and hyaluronidase-fihj in combination with VMP (D-VMP) was evaluated in a single-arm cohort of the PLEIADES trial (NCT03412565), a multi-cohort, open‑label trial.[1] Eligible participants were required to have newly diagnosed multiple myeloma and were ineligible for transplant.[1]

Efficacy of daratumumab and hyaluronidase-fihj in combination with Rd (D-Rd) was evaluated in a single-arm cohort of this trial.[1] Eligible participants had received at least one prior line of therapy.

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References
  1. "FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma". U.S. Food and Drug Administration (FDA) (Press release). 1 May 2020. Retrieved 1 May 2020. This article incorporates text from this source, which is in the public domain.
  2. "Darzalex Faspro (daratumumab and hyaluronidase-fihj) injection, for subcutaneous use" (PDF). U.S. Food and Drug Administration (FDA). Janssen. Retrieved 1 May 2020.
  3. "Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), for the Treatment of Patients with Multiple Myeloma" (Press release). Genmab. 1 May 2020. Retrieved 1 May 2020 – via GlobeNewswire.
  4. "Darzalex Faspro: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 2 May 2020.
  • "Daratumumab". Drug Information Portal. U.S. National Library of Medicine.
  • "Hyaluronidase (Human recombinant)". Drug Information Portal. U.S. National Library of Medicine.
  • Clinical trial number NCT03277105 for "A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma" at ClinicalTrials.gov
  • Clinical trial number NCT03412565 for "A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens" at ClinicalTrials.gov
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