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On July 9, 2021, the U.
S.
Food and Drug Administration (FDA) approved Darzalex Faspro (Darzalex Faspro) in combination with pomalidomide and dexamethasone for multiple myeloma ( MM) Adult patients (previously received at least first-line treatment including lenalidomide and proteasome inhibitors)
.
The approval evaluated the efficacy in the APOLLO study (NCT03180736).
The APOLLO study is an open-label, active controlled study.
304 patients were randomized (1:1) to receive Darzalex Faspro in combination with pomalidomide and dexamethasone (Darzalex Faspro- Pd) treatment or pomalidomide and dexamethasone (Pd) treatment
.
Darzalex Faspro administration method: 1800mg/30000 units (1800mg daratumumab and 30000 units hyaluronidase), subcutaneously, once a week for the first 8 weeks, and once every two weeks for the 9-24 weeks.
Every four weeks starting from the 25th week; pomalidomide administration method: on the 1-21st day of each cycle (28 days as a cycle), 4 mg orally once a day; dexamethasone administration method: 40 mg per week (for> 75-year-old patients, reduce the dose to 20mg per week)
.
Until the disease progresses or intolerable toxicity appears
.
The main study endpoint is progression-free survival (PFS)
.
The median PFS of the Darzalex Faspro-Pd group and the Pd group were 12.
4 months and 6.
9 months, respectively (HR 0.
63; 95% CI: 0.
47, 0.
85; p=0.
0018).
Compared with the Pd regimen, they received Darzalex Faspro-Pd The risk of disease progression or death in treated patients was reduced by 37%
.
The most common adverse reactions (≥20%) of MM patients receiving Darzalex Faspro-Pd treatment include fatigue, pneumonia, upper respiratory tract infection, and diarrhea
.
The recommended dose of Darzalex Faspro is 1800mg/30000 units (1800mg daratumumab and 30000 units hyaluronidase), injected subcutaneously into the abdomen within about 3-5 minutes
.
Reference source: https:// Stamp "read original text" , We make progress together
S.
Food and Drug Administration (FDA) approved Darzalex Faspro (Darzalex Faspro) in combination with pomalidomide and dexamethasone for multiple myeloma ( MM) Adult patients (previously received at least first-line treatment including lenalidomide and proteasome inhibitors)
.
The approval evaluated the efficacy in the APOLLO study (NCT03180736).
The APOLLO study is an open-label, active controlled study.
304 patients were randomized (1:1) to receive Darzalex Faspro in combination with pomalidomide and dexamethasone (Darzalex Faspro- Pd) treatment or pomalidomide and dexamethasone (Pd) treatment
.
Darzalex Faspro administration method: 1800mg/30000 units (1800mg daratumumab and 30000 units hyaluronidase), subcutaneously, once a week for the first 8 weeks, and once every two weeks for the 9-24 weeks.
Every four weeks starting from the 25th week; pomalidomide administration method: on the 1-21st day of each cycle (28 days as a cycle), 4 mg orally once a day; dexamethasone administration method: 40 mg per week (for> 75-year-old patients, reduce the dose to 20mg per week)
.
Until the disease progresses or intolerable toxicity appears
.
The main study endpoint is progression-free survival (PFS)
.
The median PFS of the Darzalex Faspro-Pd group and the Pd group were 12.
4 months and 6.
9 months, respectively (HR 0.
63; 95% CI: 0.
47, 0.
85; p=0.
0018).
Compared with the Pd regimen, they received Darzalex Faspro-Pd The risk of disease progression or death in treated patients was reduced by 37%
.
The most common adverse reactions (≥20%) of MM patients receiving Darzalex Faspro-Pd treatment include fatigue, pneumonia, upper respiratory tract infection, and diarrhea
.
The recommended dose of Darzalex Faspro is 1800mg/30000 units (1800mg daratumumab and 30000 units hyaluronidase), injected subcutaneously into the abdomen within about 3-5 minutes
.
Reference source: https:// Stamp "read original text" , We make progress together
