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In July 2021, we have summarized the new drugs and new regimens approved by the U.
S.
Food and Drug Administration (FDA) for the treatment of hematological tumors in the first half of 2021 (for details, please click: [Summary] FDA-approved for hematological tumors in the first half of 2021) New drugs and new programs for malignant tumors)
.
Today, let's review the latest FDA approval developments in the field of hematological oncology in 2021
.
July 9, 2021 FDA approves daratumumab-hyaluronidase (Darzalex Faspro) in combination with pomalidomide and dexamethasone in adult patients with multiple myeloma (MM) based on the APOLLO study (NCT03180736)
.
For details, please click: FDA Update | Approval of daratumumab-hyaluronidase in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma
.
The recommended dose of Darzalex Faspro is 1800 mg/30,000 units (1800 mg of daratumumab and 30,000 units of hyaluronidase) administered subcutaneously in the abdomen over approximately 3-5 minutes
.
July 16, 2021 FDA approves selective Rho-related coiled-coil kinase 2 (ROCK2) inhibitor belumosudil for the treatment of chronic graft-versus-host disease (cGVHD) in adults and children ≥12 years of age who have failed ≥2 previous lines of systemic therapy The approval was based on a randomized, open-label, multicenter study (KD025-213 study)
.
For details, please click: FDA Update | Approval of belumosudil for the treatment of chronic graft-versus-host disease
.
The recommended dose of belumosudil is 200 mg once daily with food
.
On August 31, 2021, the FDA approved zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia (WM) based on the ASPEN study (NCT03053440)
.
For details, please click: FDA Update | Approval of zanubrutinib for the treatment of Waldenström's macroglobulinemia
.
The recommended dose of zanubrutinib is 160 mg twice daily, or 320 mg once daily, both orally
.
On September 22, 2021, the FDA approved ruxolitinib for the treatment of adults with chronic graft-versus-host disease (cGVHD) and children ≥12 years of age who have failed first- or second-line systemic therapy.
The approval was based on the REACH-3 study (NCT03112603)
.
For details, please click: FDA Update | Approval of ruxolitinib for the treatment of chronic graft-versus-host disease
.
The recommended starting dose of ruxolitinib for the treatment of cGVHD is 10 mg orally twice daily
.
On October 1, 2021, the FDA approved brexucabtagene autoleucel for the treatment of adult patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia based on the ZUMA-3 study (NCT02614066)
.
For details, please click: FDA Update | Approval of brexucabtagene autoleucel for the treatment of patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia
.
The recommended dose of brexucabtagene autoleucel is a single intravenous infusion of 1x106 CAR-T cells per kg body weight (maximum 1x108 CAR-T cells)
.
October 29, 2021 FDA accelerated approval of asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia, including: chronic phase (CP) Philadelphia chromosome-positive patients who have received ≥2 prior tyrosine-based kinase inhibitor (TKI) therapy Chronic Myeloid Leukemia (Ph+ CML) Patients with T315I-mutated CP Ph+ CML in Adult Patients The approval is based on the ASCEMBL study (NCT03106779) and the CABL001X2101 study (NCT02081378)
.
For details, please click: FDA Update | Approval of asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia
.
The recommended asciminib dose for CP Ph+ CML patients who have received ≥2 prior TKIs is 80 mg once daily orally at approximately the same time each day, or 40 mg twice daily approximately 12 hours apart
.
The recommended asciminib dose for patients with T315I-mutated CP Ph+ CML is 200 mg orally twice daily approximately 12 hours apart
.
Nov.
30, 2021 FDA approved daratumumab-hyaluronidase (Darzalex Faspro), carfilzomib, and dexamethasone combination for relapsed or refractory (1-3 prior line therapy) ) in adult patients with multiple myeloma (RRMM) The approval was based on a single-arm, multi-cohort, open-label study of PLEIADES (NCT03412565)
.
For details, please click: FDA Update | Approval of daratumumab-hyaluronidase in combination with carfilzomib and dexamethasone for the treatment of patients with multiple myeloma
.
The recommended dose of Darzalex Faspro is 1800 mg/30,000 units (1800 mg of daratumumab and 30,000 units of hyaluronidase) subcutaneously weekly from weeks 1-8 and biweekly from weeks 9-24 , every four weeks starting at week 25 until disease progression or intolerable toxicity
.
The recommended dose regimen for carfilzomib when co-administered with Darzalex Faspro is as follows: Once weekly, 20/70 mg/m2 regimen: Carfilzomib 20 mg/m2 IV infusion over 30 minutes on Day 1 of Cycle 1, if tolerated For a dose of 20 mg/m2, 70 mg/m2 was given as a 30-minute intravenous infusion on days 8 and 15 of cycle 1, followed by infusions on days 1, 8, and 15 of each cycle, 28 days/cycle
.
Twice weekly, 20/56 mg/m2 regimen: Carfilzomib 20 mg/m2 IV infusion over 30 minutes on Days 1 and 2 of Cycle 1, or 56 mg/m2 if 20 mg/m2 dose tolerated , as a 30-minute intravenous infusion on days 8, 9, 15, and 16 of cycle 1, followed by infusions on days 1, 2, 8, 9, 15, and 16 of each cycle, 28 days/cycle
.
December 2, 2021 FDA approves rituximab in combination with chemotherapy for previously untreated, advanced, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like Pediatric patients (≥6 months to <18 years) with lymphoma (BLL) or mature B-cell acute leukemia (B-AL) The approval is based on the Inter-B-NHL Ritux 2010 study (NCT01516580).
For details, please click: FDA Update| Rituximab is approved in combination with chemotherapy for selected pediatric patients with hematological malignancies
.
The recommended dose of rituximab is 375 mg/m2, intravenously, administered in combination with LMB chemotherapy
.
A total of 6 infusions of rituximab were given, 2 in each induction session (COPDAM1 [cyclophosphamide, vincristine, prednisolone, doxorubicin, methotrexate] and COPDAM2) , once during each consolidation session (CYM [cytarabine, methotrexate] and CYVE)
.
December 15, 2021 FDA approves abatacept in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) for the prevention of acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation in children ≥2 years of age and adults ) This approval is based on two studies in patients ≥6 years of age who received HSCT from matched or 1 allelic mismatched unrelated donors, for details please click: FDA Updates | Approval of abatacept for the prevention of acute graft-versus-host disease
.
Reference: [1] https:// ]https:// /resources-information-approved-drugs/fda-approves-zanubrutinib-waldenstroms-macroglobulinemia.
[4]https:// graft-versus-host-disease.
[5]https:// -acute-lymphoblastic.
[6]https:// :// -approved-drugs/fda-approves-rituximab-plus-chemotherapy-pediatric-cancer-indications.
[9]https:// prophylaxis-acute-graft-versus-host-disease.
Click "read the original text", we will progress together
S.
Food and Drug Administration (FDA) for the treatment of hematological tumors in the first half of 2021 (for details, please click: [Summary] FDA-approved for hematological tumors in the first half of 2021) New drugs and new programs for malignant tumors)
.
Today, let's review the latest FDA approval developments in the field of hematological oncology in 2021
.
July 9, 2021 FDA approves daratumumab-hyaluronidase (Darzalex Faspro) in combination with pomalidomide and dexamethasone in adult patients with multiple myeloma (MM) based on the APOLLO study (NCT03180736)
.
For details, please click: FDA Update | Approval of daratumumab-hyaluronidase in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma
.
The recommended dose of Darzalex Faspro is 1800 mg/30,000 units (1800 mg of daratumumab and 30,000 units of hyaluronidase) administered subcutaneously in the abdomen over approximately 3-5 minutes
.
July 16, 2021 FDA approves selective Rho-related coiled-coil kinase 2 (ROCK2) inhibitor belumosudil for the treatment of chronic graft-versus-host disease (cGVHD) in adults and children ≥12 years of age who have failed ≥2 previous lines of systemic therapy The approval was based on a randomized, open-label, multicenter study (KD025-213 study)
.
For details, please click: FDA Update | Approval of belumosudil for the treatment of chronic graft-versus-host disease
.
The recommended dose of belumosudil is 200 mg once daily with food
.
On August 31, 2021, the FDA approved zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia (WM) based on the ASPEN study (NCT03053440)
.
For details, please click: FDA Update | Approval of zanubrutinib for the treatment of Waldenström's macroglobulinemia
.
The recommended dose of zanubrutinib is 160 mg twice daily, or 320 mg once daily, both orally
.
On September 22, 2021, the FDA approved ruxolitinib for the treatment of adults with chronic graft-versus-host disease (cGVHD) and children ≥12 years of age who have failed first- or second-line systemic therapy.
The approval was based on the REACH-3 study (NCT03112603)
.
For details, please click: FDA Update | Approval of ruxolitinib for the treatment of chronic graft-versus-host disease
.
The recommended starting dose of ruxolitinib for the treatment of cGVHD is 10 mg orally twice daily
.
On October 1, 2021, the FDA approved brexucabtagene autoleucel for the treatment of adult patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia based on the ZUMA-3 study (NCT02614066)
.
For details, please click: FDA Update | Approval of brexucabtagene autoleucel for the treatment of patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia
.
The recommended dose of brexucabtagene autoleucel is a single intravenous infusion of 1x106 CAR-T cells per kg body weight (maximum 1x108 CAR-T cells)
.
October 29, 2021 FDA accelerated approval of asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia, including: chronic phase (CP) Philadelphia chromosome-positive patients who have received ≥2 prior tyrosine-based kinase inhibitor (TKI) therapy Chronic Myeloid Leukemia (Ph+ CML) Patients with T315I-mutated CP Ph+ CML in Adult Patients The approval is based on the ASCEMBL study (NCT03106779) and the CABL001X2101 study (NCT02081378)
.
For details, please click: FDA Update | Approval of asciminib for the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia
.
The recommended asciminib dose for CP Ph+ CML patients who have received ≥2 prior TKIs is 80 mg once daily orally at approximately the same time each day, or 40 mg twice daily approximately 12 hours apart
.
The recommended asciminib dose for patients with T315I-mutated CP Ph+ CML is 200 mg orally twice daily approximately 12 hours apart
.
Nov.
30, 2021 FDA approved daratumumab-hyaluronidase (Darzalex Faspro), carfilzomib, and dexamethasone combination for relapsed or refractory (1-3 prior line therapy) ) in adult patients with multiple myeloma (RRMM) The approval was based on a single-arm, multi-cohort, open-label study of PLEIADES (NCT03412565)
.
For details, please click: FDA Update | Approval of daratumumab-hyaluronidase in combination with carfilzomib and dexamethasone for the treatment of patients with multiple myeloma
.
The recommended dose of Darzalex Faspro is 1800 mg/30,000 units (1800 mg of daratumumab and 30,000 units of hyaluronidase) subcutaneously weekly from weeks 1-8 and biweekly from weeks 9-24 , every four weeks starting at week 25 until disease progression or intolerable toxicity
.
The recommended dose regimen for carfilzomib when co-administered with Darzalex Faspro is as follows: Once weekly, 20/70 mg/m2 regimen: Carfilzomib 20 mg/m2 IV infusion over 30 minutes on Day 1 of Cycle 1, if tolerated For a dose of 20 mg/m2, 70 mg/m2 was given as a 30-minute intravenous infusion on days 8 and 15 of cycle 1, followed by infusions on days 1, 8, and 15 of each cycle, 28 days/cycle
.
Twice weekly, 20/56 mg/m2 regimen: Carfilzomib 20 mg/m2 IV infusion over 30 minutes on Days 1 and 2 of Cycle 1, or 56 mg/m2 if 20 mg/m2 dose tolerated , as a 30-minute intravenous infusion on days 8, 9, 15, and 16 of cycle 1, followed by infusions on days 1, 2, 8, 9, 15, and 16 of each cycle, 28 days/cycle
.
December 2, 2021 FDA approves rituximab in combination with chemotherapy for previously untreated, advanced, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like Pediatric patients (≥6 months to <18 years) with lymphoma (BLL) or mature B-cell acute leukemia (B-AL) The approval is based on the Inter-B-NHL Ritux 2010 study (NCT01516580).
For details, please click: FDA Update| Rituximab is approved in combination with chemotherapy for selected pediatric patients with hematological malignancies
.
The recommended dose of rituximab is 375 mg/m2, intravenously, administered in combination with LMB chemotherapy
.
A total of 6 infusions of rituximab were given, 2 in each induction session (COPDAM1 [cyclophosphamide, vincristine, prednisolone, doxorubicin, methotrexate] and COPDAM2) , once during each consolidation session (CYM [cytarabine, methotrexate] and CYVE)
.
December 15, 2021 FDA approves abatacept in combination with a calcineurin inhibitor (CNI) and methotrexate (MTX) for the prevention of acute graft-versus-host disease (aGVHD) after hematopoietic stem cell transplantation in children ≥2 years of age and adults ) This approval is based on two studies in patients ≥6 years of age who received HSCT from matched or 1 allelic mismatched unrelated donors, for details please click: FDA Updates | Approval of abatacept for the prevention of acute graft-versus-host disease
.
Reference: [1] https:// ]https:// /resources-information-approved-drugs/fda-approves-zanubrutinib-waldenstroms-macroglobulinemia.
[4]https:// graft-versus-host-disease.
[5]https:// -acute-lymphoblastic.
[6]https:// :// -approved-drugs/fda-approves-rituximab-plus-chemotherapy-pediatric-cancer-indications.
[9]https:// prophylaxis-acute-graft-versus-host-disease.
Click "read the original text", we will progress together
