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In the first half of 2021, what new drugs and new programs have been approved by the FDA for hematological malignancies? Multiple myeloma, follicular lymphoma, large B-cell lymphoma.
.
.
the progress of new drugs should not be missed! On January 14, 2021, the FDA approved crizotinib for children and adolescents with relapsed or refractory systemic anaplastic large cell lymphoma.
The approval is based on the ADVL0912 study.
For details, please stamp: January 2021 FDA approved for blood New drugs and new regimens for malignant tumors For systemic ALCL, the recommended dose of crizotinib is 280 mg/m2 twice a day
.
For ALCL patients, it is recommended to use antiemetics before and during treatment with crizotinib
.
Due to the risk of vision loss, it is recommended to perform an ophthalmological assessment at baseline and monthly vision and visual symptom assessments thereafter
.
On January 15, 2021, the FDA accelerates the approval of daratumomab-hyaluronidase combined with bortezomib + cyclophosphamide + dexamethasone for the treatment of newly diagnosed patients with light chain amyloidosis.
The approval is based on the ANDROMEDA study, details Please stamp: In January 2021, the FDA approved a new drug and a new program for hematological malignancies.
The recommended dose of daretuzumab-hyaluronidase is 1800mg of daretuzumab and 30,000 units of hyaluronidase.
According to the recommended schedule, rapturumab-hyaluronidase is combined with VCd and injected into the abdomen subcutaneously within about 3-5 minutes
.
On February 5, 2021, the FDA accelerated the approval of Umbralisib for the treatment of marginal zone lymphoma and follicular lymphoma.
The accelerated approval is based on the UTX-TGR-205 study.
For details, please click: FDA Update | Accelerated Approval of Umbralisib for the treatment of marginal zone lymphoma and The recommended dose of umbralisib for patients with follicular lymphoma is 800 mg, orally once a day, with food until the disease progresses or unacceptable toxicity
.
On February 5, 2021, the FDA approved lisocabtagene maraleucel for the treatment of relapsed/refractory large B-cell lymphoma.
Lisocabtagene maraleucel is a T cell immunotherapy targeting CD19 chimeric antigen receptor (CAR)
.
It is composed of autologous T cells that have been genetically modified to produce CAR protein, so that T cells can recognize and eliminate normal and tumor cells that express CD19
.
The approval is based on the TRANSCEND study.
For details, please click: FDA update | Approval of lisocabtagene maraleucel for the treatment of relapsed/refractory large B-cell lymphoma.
The recommended treatment plan is to use fludarabine and cyclophosphamide for lymphocyte clearance, a single dose Intravenous infusion of 50-110x106 CAR-T cells
.
Lisocabtagene maraleucel is not suitable for the treatment of patients with primary central nervous system lymphoma
.
On February 26, 2021, the FDA accelerated the approval of Melphalan Flufenamide for the treatment of patients with relapsed and refractory multiple myeloma.
The accelerated approval is based on a multi-center, single-arm HORIZON study.
For details, please click: FDA Update | Accelerated Approval of Melphalan Flufenamide for the treatment of relapsed and refractory patients The recommended dose of Melphalan flufenamide for patients with multiple myeloma 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
.
On March 5, 2021, the FDA accelerated the approval of axicabtagene ciloleucel for the treatment of relapsed and refractory follicular lymphoma.
The accelerated approval is based on the ZUMA-5 study.
For details, please click: FDA update | accelerated approval of axicabtagene ciloleucel for the treatment of relapsed and refractory follicles Idecabtagene vicleucel is a genetically modified auto-chimeric antigen receptor targeting B cell maturation antigen (BCMA) that targets BCMA CAR-T cell therapy idecabtagene vicleucel for the treatment of multiple myeloma patients ( CAR) T cell therapy is customized using the patient's own T cells.
These T cells will be collected, genetically modified, and then injected into the patient
.
For details, please poke: FDA update | Approved targeted BCMA CAR-T cell therapy idecabtagene vicleucel for the treatment of multiple myeloma patients March 31, 2021 FDA approved isatuximab-irfc for the treatment of multiple myeloma patients IKEMA study (NCT03275285) is a multinational , Multicenter, randomized, open-label, two-arm, phase 3 study, which evaluated the efficacy and safety of isatuximab-irfc combined with carfilzomib and dexamethasone in RRMM patients who have previously received 1-3 lines of treatment
.
For more details, please click: FDA Update | Approval of isatuximab-irfc for the treatment of multiple myeloma patients when combined with carfilzomib and dexamethasone, the recommended dose of Isatuximab-irfc is 10mg/kg, intravenous infusion once a week for 4 weeks , And then every two weeks until the disease progresses or intolerable toxicity occurs
.
On April 23, 2021, the FDA accelerated approval of loncastuximab tesirine-lpyl for the treatment of large B-cell lymphoma patients.
The approval is based on the LOTIS-2 study.
For details, please click: FDA update | accelerated approval of loncastuximab tesirine-lpyl for the treatment of large B-cell lymphoma patients recommended The 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 it needs more than 30 minutes of intravenous infusion 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
.
FDA approved avapritinib for the treatment of advanced systemic mastocytosis on June 16, 2021.
Avapritinib was evaluated for AdvSM in two multicenter, single-arm, open-label clinical studies (EXPLORER study [NCT02561988] and PATHFINDER study [NCT03580655]) The curative effect
.
For details, please click: FDA Update | Approval of avapritinib for the treatment of advanced systemic mastocytosis.
It is not recommended to use avapritinib for the treatment of AdvSM patients with platelet counts below 50×109/L
.
For AdvSM patients, the recommended dose of vapritinib is 200 mg, once a day, orally
.
FDA approved asparaginase erwinia chrysanthemi (recombinant) for the treatment of leukemia and lymphoma on June 30, 2021.
On June 30, 2021, the US Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant) Asparaginase) is used in a multi-drug chemotherapy regimen for children and adult patients (≥1 month) with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) allergic to E.
coli-derived asparaginase
.
The efficacy was evaluated in the JZP458-201 study (NCT04145531)
.
The JZP458-201 study is an open-label, multi-cohort, multi-center study.
102 patients with ALL or LBL allergic to E.
coli-derived asparaginase (a component of a multi-drug chemotherapy regimen) were included in the study, with a median age 10 years old (range: 1-24 years old)
.
The patient was injected intramuscularly with different doses of asparaginase erwinia chrysanthemi (recombinant)
.
The main outcome measure is to achieve and maintain a minimum serum asparaginase activity (NSAA) ≥0.
1U/mL
.
The results of the study showed that when a dose of 25 mg/m2 was injected intramuscularly every 48 hours, the proportion of patients with NSAA ≥ 0.
1 U/mL after 48 hours of administration was 93.
6% (95% CI: 92.
6%, 94.
6%)
.
The most common adverse reactions (incidence rate> 20%) are abnormal liver function tests, nausea, musculoskeletal pain, fatigue, infection, headache, fever, drug allergy, febrile neutropenia, decreased appetite, stomatitis, bleeding And high blood sugar
.
The recommended dose of asparaginase erwinia chrysanthemi (recombinant) is 25mg/m2, injected intramuscularly every 48 hours
.
Reference source: 1.
https:// .
2.
https:// 3.
https:/ / 4.
https:// /drugs/drug-approvals-and-databases/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma.
5.
https:// -and-databases/fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple-myeloma.
6.
https:// 7.
https:// approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// myeloma.
9.
https:// 10.
https:// drugs/drug-approvals-and-databases/fda-approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/drug-approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// isatuximab-irfc-multiple-myeloma.
9.
https:// 10.
https:// https:// fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/drug-approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// isatuximab-irfc-multiple-myeloma.
9.
https:// 10.
https:// https:// fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma.
10.
https:// approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// Poke "read the original text", we make progress togethergov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma.
10.
https:// approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// Poke "read the original text", we make progress together
.
.
the progress of new drugs should not be missed! On January 14, 2021, the FDA approved crizotinib for children and adolescents with relapsed or refractory systemic anaplastic large cell lymphoma.
The approval is based on the ADVL0912 study.
For details, please stamp: January 2021 FDA approved for blood New drugs and new regimens for malignant tumors For systemic ALCL, the recommended dose of crizotinib is 280 mg/m2 twice a day
.
For ALCL patients, it is recommended to use antiemetics before and during treatment with crizotinib
.
Due to the risk of vision loss, it is recommended to perform an ophthalmological assessment at baseline and monthly vision and visual symptom assessments thereafter
.
On January 15, 2021, the FDA accelerates the approval of daratumomab-hyaluronidase combined with bortezomib + cyclophosphamide + dexamethasone for the treatment of newly diagnosed patients with light chain amyloidosis.
The approval is based on the ANDROMEDA study, details Please stamp: In January 2021, the FDA approved a new drug and a new program for hematological malignancies.
The recommended dose of daretuzumab-hyaluronidase is 1800mg of daretuzumab and 30,000 units of hyaluronidase.
According to the recommended schedule, rapturumab-hyaluronidase is combined with VCd and injected into the abdomen subcutaneously within about 3-5 minutes
.
On February 5, 2021, the FDA accelerated the approval of Umbralisib for the treatment of marginal zone lymphoma and follicular lymphoma.
The accelerated approval is based on the UTX-TGR-205 study.
For details, please click: FDA Update | Accelerated Approval of Umbralisib for the treatment of marginal zone lymphoma and The recommended dose of umbralisib for patients with follicular lymphoma is 800 mg, orally once a day, with food until the disease progresses or unacceptable toxicity
.
On February 5, 2021, the FDA approved lisocabtagene maraleucel for the treatment of relapsed/refractory large B-cell lymphoma.
Lisocabtagene maraleucel is a T cell immunotherapy targeting CD19 chimeric antigen receptor (CAR)
.
It is composed of autologous T cells that have been genetically modified to produce CAR protein, so that T cells can recognize and eliminate normal and tumor cells that express CD19
.
The approval is based on the TRANSCEND study.
For details, please click: FDA update | Approval of lisocabtagene maraleucel for the treatment of relapsed/refractory large B-cell lymphoma.
The recommended treatment plan is to use fludarabine and cyclophosphamide for lymphocyte clearance, a single dose Intravenous infusion of 50-110x106 CAR-T cells
.
Lisocabtagene maraleucel is not suitable for the treatment of patients with primary central nervous system lymphoma
.
On February 26, 2021, the FDA accelerated the approval of Melphalan Flufenamide for the treatment of patients with relapsed and refractory multiple myeloma.
The accelerated approval is based on a multi-center, single-arm HORIZON study.
For details, please click: FDA Update | Accelerated Approval of Melphalan Flufenamide for the treatment of relapsed and refractory patients The recommended dose of Melphalan flufenamide for patients with multiple myeloma 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
.
On March 5, 2021, the FDA accelerated the approval of axicabtagene ciloleucel for the treatment of relapsed and refractory follicular lymphoma.
The accelerated approval is based on the ZUMA-5 study.
For details, please click: FDA update | accelerated approval of axicabtagene ciloleucel for the treatment of relapsed and refractory follicles Idecabtagene vicleucel is a genetically modified auto-chimeric antigen receptor targeting B cell maturation antigen (BCMA) that targets BCMA CAR-T cell therapy idecabtagene vicleucel for the treatment of multiple myeloma patients ( CAR) T cell therapy is customized using the patient's own T cells.
These T cells will be collected, genetically modified, and then injected into the patient
.
For details, please poke: FDA update | Approved targeted BCMA CAR-T cell therapy idecabtagene vicleucel for the treatment of multiple myeloma patients March 31, 2021 FDA approved isatuximab-irfc for the treatment of multiple myeloma patients IKEMA study (NCT03275285) is a multinational , Multicenter, randomized, open-label, two-arm, phase 3 study, which evaluated the efficacy and safety of isatuximab-irfc combined with carfilzomib and dexamethasone in RRMM patients who have previously received 1-3 lines of treatment
.
For more details, please click: FDA Update | Approval of isatuximab-irfc for the treatment of multiple myeloma patients when combined with carfilzomib and dexamethasone, the recommended dose of Isatuximab-irfc is 10mg/kg, intravenous infusion once a week for 4 weeks , And then every two weeks until the disease progresses or intolerable toxicity occurs
.
On April 23, 2021, the FDA accelerated approval of loncastuximab tesirine-lpyl for the treatment of large B-cell lymphoma patients.
The approval is based on the LOTIS-2 study.
For details, please click: FDA update | accelerated approval of loncastuximab tesirine-lpyl for the treatment of large B-cell lymphoma patients recommended The 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 it needs more than 30 minutes of intravenous infusion 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
.
FDA approved avapritinib for the treatment of advanced systemic mastocytosis on June 16, 2021.
Avapritinib was evaluated for AdvSM in two multicenter, single-arm, open-label clinical studies (EXPLORER study [NCT02561988] and PATHFINDER study [NCT03580655]) The curative effect
.
For details, please click: FDA Update | Approval of avapritinib for the treatment of advanced systemic mastocytosis.
It is not recommended to use avapritinib for the treatment of AdvSM patients with platelet counts below 50×109/L
.
For AdvSM patients, the recommended dose of vapritinib is 200 mg, once a day, orally
.
FDA approved asparaginase erwinia chrysanthemi (recombinant) for the treatment of leukemia and lymphoma on June 30, 2021.
On June 30, 2021, the US Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant) Asparaginase) is used in a multi-drug chemotherapy regimen for children and adult patients (≥1 month) with acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) allergic to E.
coli-derived asparaginase
.
The efficacy was evaluated in the JZP458-201 study (NCT04145531)
.
The JZP458-201 study is an open-label, multi-cohort, multi-center study.
102 patients with ALL or LBL allergic to E.
coli-derived asparaginase (a component of a multi-drug chemotherapy regimen) were included in the study, with a median age 10 years old (range: 1-24 years old)
.
The patient was injected intramuscularly with different doses of asparaginase erwinia chrysanthemi (recombinant)
.
The main outcome measure is to achieve and maintain a minimum serum asparaginase activity (NSAA) ≥0.
1U/mL
.
The results of the study showed that when a dose of 25 mg/m2 was injected intramuscularly every 48 hours, the proportion of patients with NSAA ≥ 0.
1 U/mL after 48 hours of administration was 93.
6% (95% CI: 92.
6%, 94.
6%)
.
The most common adverse reactions (incidence rate> 20%) are abnormal liver function tests, nausea, musculoskeletal pain, fatigue, infection, headache, fever, drug allergy, febrile neutropenia, decreased appetite, stomatitis, bleeding And high blood sugar
.
The recommended dose of asparaginase erwinia chrysanthemi (recombinant) is 25mg/m2, injected intramuscularly every 48 hours
.
Reference source: 1.
https:// .
2.
https:// 3.
https:/ / 4.
https:// /drugs/drug-approvals-and-databases/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-large-b-cell-lymphoma.
5.
https:// -and-databases/fda-grants-accelerated-approval-melphalan-flufenamide-relapsed-or-refractory-multiple-myeloma.
6.
https:// 7.
https:// approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// myeloma.
9.
https:// 10.
https:// drugs/drug-approvals-and-databases/fda-approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/drug-approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// isatuximab-irfc-multiple-myeloma.
9.
https:// 10.
https:// https:// fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/drug-approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma.
8.
https:// isatuximab-irfc-multiple-myeloma.
9.
https:// 10.
https:// https:// fda-approves-asparaginase-erwinia-chrysanthemi-recombinant-leukemia-and-lymphoma.
Stamp "read the original text", we make progress togethergov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma.
10.
https:// approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// Poke "read the original text", we make progress togethergov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma.
10.
https:// approves-avapritinib-advanced-systemic-mastocytosis.
11.
https:// Poke "read the original text", we make progress together
