Английская Википедия:Daratumumab/hyaluronidase
Шаблон:Short description Шаблон:Use American English Шаблон:Use dmy dates Шаблон:Infobox drug
Daratumumab/hyaluronidase, sold under the brand name Darzalex Faspro, is a fixed-dose combination medication for the treatment of adults with newly diagnosed or relapsed/refractory multiple myeloma.[1][2][3] It is a combination of daratumumab and hyaluronidase.[2] It is administered via subcutaneous injection.[2]
The most common adverse reaction using daratumumab/hyaluronidase as monotherapy is upper respiratory tracts infection.[2] The most common adverse reactions (≥20%) in people with amyloid light-chain amyloidosis who received daratumumab/hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone are upper respiratory tract infection, diarrhea, peripheral edema, constipation peripheral sensory neuropathy, fatigue, nausea, insomnia, dyspnea and cough.[4] The most common adverse reactions (≥20%) occurring in people treated with daratumumab/hyaluronidase, carfilzomib, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.[5]
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]
In January 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to daratumumab/hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed amyloid light-chain amyloidosis.[4]
In November 2021, the FDA granted approval to daratumumab/hyaluronidase in combination with carfilzomib plus dexamethasone to treat relapsed or refractory multiple myeloma in adults who have received one to three prior lines of therapy.[5]
History
It was approved for use in the United States in May 2020.[1][6][7]
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.
Efficacy of daratumumab/hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone was evaluated in ANDROMEDA (NCT03201965), an open-label, randomized, active-controlled trial in 388 participants with newly diagnosed amyloid light-chain amyloidosis with measurable disease and at least one affected organ according to consensus criteria.[4] Participants were randomized to receive bortezomib, cyclophosphamide, and dexamethasone (VCd arm) or with daratumumab and hyaluronidase (D-VCd arm).[4]
Efficacy of daratumumab/hyaluronidase in combination with carfilzomib and dexamethasone was evaluated in PLEIADES (NCT03412565), a multi-cohort, open-label trial.[5]
References
External links
- Шаблон:Cite web
- Шаблон:Cite web
- Шаблон:ClinicalTrialsGov
- Шаблон:ClinicalTrialsGov
- Шаблон:ClinicalTrialsGov
- ↑ 1,00 1,01 1,02 1,03 1,04 1,05 1,06 1,07 1,08 1,09 1,10 1,11 1,12 Шаблон:Cite press release Шаблон:PD-notice
- ↑ 2,0 2,1 2,2 2,3 2,4 2,5 2,6 2,7 Ошибка цитирования Неверный тег
<ref>; для сносокDarzalex Faspro FDA labelне указан текст - ↑ Шаблон:Cite journal
- ↑ 4,0 4,1 4,2 4,3 Шаблон:Cite web Шаблон:PD-notice
- ↑ 5,0 5,1 5,2 Шаблон:Cite web Шаблон:PD-notice
- ↑ Шаблон:Cite press release
- ↑ Шаблон:Cite web
