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On February 26, 2021, the U.
S.
Food and Drug Administration (FDA) accelerated the approval of melphalan flufenamide combined with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (previously receiving ≥4-line therapy and inhibiting at least one proteasome Drugs, an immunomodulator and a CD38 monoclonal antibody are ineffective).
The accelerated approval is based on the multi-center, single-arm HORIZON study (NCT02963493).
The HORIZON study included eligible patients with relapsed and refractory multiple myeloma.
Patients receive 40 mg melphalan flufenamide intravenously on the first day of each cycle, and 40 mg orally (20 mg orally for patients ≥75 years of age) on days 1, 8, 15 and 22 of each cycle (28 days as a cycle).
Until the disease progresses or intolerable toxicity appears.
Efficacy was evaluated in a subgroup of 97 patients who had previously received ≥4-line therapy and were ineffective against at least one proteasome inhibitor, one immunomodulator, and one CD38 monoclonal antibody.
The main efficacy indicators are the overall response rate (ORR) and duration of response (DOR) assessed by the investigator according to the International Myeloma Working Group (IMWG) standards.
The ORR was 23.
7% (95% CI: 15.
7, 33.
4), and the median DOR was 4.
2 months (95% CI: 3.
2, 7.
6).
Safety was evaluated in 157 patients.
The most common adverse reactions (>20%) are fatigue, nausea, diarrhea, fever and respiratory infections.
The most common laboratory abnormalities (≥50%) are a decrease in white blood cells, platelets, lymphocytes, neutrophils, and hemoglobin, and an increase in creatinine.
The safety and effectiveness of Melphalan flufenamide for pretreatment of transplant patients have not been determined.
The USPI's use restriction statement stated that melphalan flufenamide is not suitable and not recommended for transplantation pretreatment outside of controlled clinical trials.
The recommended dose of Melphalan flufenamide is 40 mg intravenous infusion on the first day of each cycle (28 days as a cycle) (each infusion time is more than 30 minutes), and combined with dexamethasone.
Reference source: https:// Stamp "read the original" , We make progress together
S.
Food and Drug Administration (FDA) accelerated the approval of melphalan flufenamide combined with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma (previously receiving ≥4-line therapy and inhibiting at least one proteasome Drugs, an immunomodulator and a CD38 monoclonal antibody are ineffective).
The accelerated approval is based on the multi-center, single-arm HORIZON study (NCT02963493).
The HORIZON study included eligible patients with relapsed and refractory multiple myeloma.
Patients receive 40 mg melphalan flufenamide intravenously on the first day of each cycle, and 40 mg orally (20 mg orally for patients ≥75 years of age) on days 1, 8, 15 and 22 of each cycle (28 days as a cycle).
Until the disease progresses or intolerable toxicity appears.
Efficacy was evaluated in a subgroup of 97 patients who had previously received ≥4-line therapy and were ineffective against at least one proteasome inhibitor, one immunomodulator, and one CD38 monoclonal antibody.
The main efficacy indicators are the overall response rate (ORR) and duration of response (DOR) assessed by the investigator according to the International Myeloma Working Group (IMWG) standards.
The ORR was 23.
7% (95% CI: 15.
7, 33.
4), and the median DOR was 4.
2 months (95% CI: 3.
2, 7.
6).
Safety was evaluated in 157 patients.
The most common adverse reactions (>20%) are fatigue, nausea, diarrhea, fever and respiratory infections.
The most common laboratory abnormalities (≥50%) are a decrease in white blood cells, platelets, lymphocytes, neutrophils, and hemoglobin, and an increase in creatinine.
The safety and effectiveness of Melphalan flufenamide for pretreatment of transplant patients have not been determined.
The USPI's use restriction statement stated that melphalan flufenamide is not suitable and not recommended for transplantation pretreatment outside of controlled clinical trials.
The recommended dose of Melphalan flufenamide is 40 mg intravenous infusion on the first day of each cycle (28 days as a cycle) (each infusion time is more than 30 minutes), and combined with dexamethasone.
Reference source: https:// Stamp "read the original" , We make progress together
