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.

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
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.