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On April 23, 2021, the U.
S.
Food and Drug Administration (FDA) accelerated the approval of the CD19-targeting antibody conjugate (ADC) loncastuximab tesirine-lpyl for relapsed/refractory patients who had previously received more than two systemic therapies.
Adult patients with cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), low-grade lymphoma caused by DLBCL, and high-grade B-cell lymphoma.
The approval is based on the LOTIS-2 study (NCT03589469).
The LOTIS-2 study is an open-label, single-arm, phase 2 clinical trial of 145 adult patients with relapsed/refractory DLCBL or high-grade B-cell lymphoma who have previously received more than two systemic therapies.
In the first two treatment cycles, patients received loncastuximab tesirine-lpyl 0.
15 mg/kg every 3 weeks; in the subsequent treatment cycles, patients received loncastuximab tesirine-lpyl 0.
075 mg/kg every 3 weeks.
Until the disease progresses or intolerable toxicity appears.
The main efficacy indicator is the overall response rate (ORR) assessed by the independent review committee.
The results showed that the ORR was 48.
3% (95% CI: 39.
9-56.
7), and the complete response (CR) rate was 24.
1% (95% CI: 17.
4-31.
9).
The median follow-up was 7.
3 months, and the median remission time was 10.
3 months (95%CI: 6.
9-NE). The most common adverse reactions (≥20%) in patients receiving loncastuximab tesirine-lpyl treatment include thrombocytopenia, elevated γ-glutamyltransferase, neutropenia, anemia, hyperglycemia, elevated transaminase, fatigue, Hypoalbuminemia, skin rash, edema, nausea, and musculoskeletal pain.
The prescription information provides warnings and preventive measures for adverse reactions including edema and effusion, bone marrow suppression, infection, and skin reactions.
The recommended dose of loncastuximab tesirine-lpyl is: in the first two treatment cycles, patients receive loncastuximab tesirine-lpyl 0.
15mg/kg every 3 weeks, and in the subsequent treatment cycles, receive loncastuximab tesirine-lpyl 0.
075mg/kg every 3 weeks , And need an intravenous infusion for more than 30 minutes on the first day of each cycle.
In addition, starting from the day before the administration of loncastuximab tesirine-lpyl, patients were given dexamethasone 4 mg orally or intravenously twice a day for 3 days.
Reference source: Stamp "read the original text" and we will make progress together
S.
Food and Drug Administration (FDA) accelerated the approval of the CD19-targeting antibody conjugate (ADC) loncastuximab tesirine-lpyl for relapsed/refractory patients who had previously received more than two systemic therapies.
Adult patients with cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), low-grade lymphoma caused by DLBCL, and high-grade B-cell lymphoma.
The approval is based on the LOTIS-2 study (NCT03589469).
The LOTIS-2 study is an open-label, single-arm, phase 2 clinical trial of 145 adult patients with relapsed/refractory DLCBL or high-grade B-cell lymphoma who have previously received more than two systemic therapies.
In the first two treatment cycles, patients received loncastuximab tesirine-lpyl 0.
15 mg/kg every 3 weeks; in the subsequent treatment cycles, patients received loncastuximab tesirine-lpyl 0.
075 mg/kg every 3 weeks.
Until the disease progresses or intolerable toxicity appears.
The main efficacy indicator is the overall response rate (ORR) assessed by the independent review committee.
The results showed that the ORR was 48.
3% (95% CI: 39.
9-56.
7), and the complete response (CR) rate was 24.
1% (95% CI: 17.
4-31.
9).
The median follow-up was 7.
3 months, and the median remission time was 10.
3 months (95%CI: 6.
9-NE). The most common adverse reactions (≥20%) in patients receiving loncastuximab tesirine-lpyl treatment include thrombocytopenia, elevated γ-glutamyltransferase, neutropenia, anemia, hyperglycemia, elevated transaminase, fatigue, Hypoalbuminemia, skin rash, edema, nausea, and musculoskeletal pain.
The prescription information provides warnings and preventive measures for adverse reactions including edema and effusion, bone marrow suppression, infection, and skin reactions.
The recommended dose of loncastuximab tesirine-lpyl is: in the first two treatment cycles, patients receive loncastuximab tesirine-lpyl 0.
15mg/kg every 3 weeks, and in the subsequent treatment cycles, receive loncastuximab tesirine-lpyl 0.
075mg/kg every 3 weeks , And need an intravenous infusion for more than 30 minutes on the first day of each cycle.
In addition, starting from the day before the administration of loncastuximab tesirine-lpyl, patients were given dexamethasone 4 mg orally or intravenously twice a day for 3 days.
Reference source: Stamp "read the original text" and we will make progress together
