WARNINGS
Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.
There are no controlled trials demonstrating efficacy and safety using Mylotarg in combination with other chemotherapeutic agents. Therefore, Mylotarg should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.
Severe myelosuppression occurs when Mylotarg is used at recommended doses.
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS, INFUSION REACTIONS, PULMONARY EVENTS
Mylotarg administration can result in severe hypersensitivity reactions (including anaphylaxis), and other infusion-related reactions which may include severe pulmonary events. Infrequently, hypersensitivity reactions and pulmonary events have been fatal. In most cases, infusion-related symptoms occurred during the infusion or within 24 hours of administration of Mylotarg and resolved. Mylotarg infusion should be interrupted for patients experiencing dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Discontinuation of Mylotarg treatment should be strongly considered for patients who develop anaphylaxis, pulmonary edema, or acute respiratory distress syndrome. Since patients with high peripheral blast counts may be at greater risk for pulmonary events and tumor lysis syndrome, physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white count to below 30,000/μL prior to administration of Mylotarg. (See WARNINGS.)
HEPATOTOXICITY:
Hepatotoxicity, including severe hepatic veno-occlusive disease (VOD), has been reported in association with the use of Mylotarg as a single agent, as part of a combination chemotherapy regimen, and in patients without a history of liver disease or hematopoietic stem cell transplant (HSCT). Patients who receive Mylotarg either before or after HSCT, patients with underlying hepatic disease or abnormal liver function, and patients receiving Mylotarg in combinations with other chemotherapy are at increased risk for developing VOD, including severe VOD. Death from liver failure and from VOD has been reported in patients who received Mylotarg. Physicians should monitor their patients carefully for symptoms of hepatotoxicity, particularly VOD. These symptoms can include: rapid weight gain, right upper quadrant pain, hepatomegaly, ascites, elevations in bilirubin and/or liver enzymes. However, careful monitoring may not identify all patients at risk or prevent the complications of hepatotoxicity. (See WARNINGS and ADVERSE REACTIONS sections.)
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MYLOTARG SUMMARY
Mylotarg® (gemtuzumab ozogamicin for Injection) is a chemotherapy agent composed of a recombinant humanized IgG4, kappa antibody conjugated with a cytotoxic antitumor antibiotic, calicheamicin, isolated from fermentation of a bacterium, Micromonospora echinospora ssp. calichensis.
Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy. The safety and efficacy of Mylotarg in patients with poor performance status and organ dysfunction has not been established.
The effectiveness of Mylotarg is based on OR rates (see CLINICAL STUDIES section). There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival, compared to any other treatment.
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NEWS HIGHLIGHTSMedia Articles Related to Mylotarg (Gemtuzumab Ozogamicin)
Sunesis' Voreloxin Receives FDA Orphan Drug Designation For Acute Myeloid Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.06]
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) announced that the U.S. Food and Drug Administration has granted voreloxin orphan drug designation for the treatment of acute myeloid leukemia (AML).
Sunesis Completes Enrollment Of Voreloxin REVEAL-1 Trial In Acute Myeloid Leukemia
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.10.31]
Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported that it has completed enrollment in the REVEAL-1 (Response Evaluation of VorEloxin in AmL) trial, a Phase 2 dose regimen optimization trial of single agent voreloxin in newly diagnosed elderly acute myeloid leukemia (AML) patients who are unlikely to benefit from standard induction chemotherapy. A total of 113 patients were enrolled and dosed according to one of three dosing schedules.
EpiCept Corporation Announces Health Canada Accepts Ceplene(R) Application For Review
Source: Blood / Hematology News From Medical News Today [2009.11.10]
EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that Health Canada has accepted for review the Company's New Drug Submission (NDS) for Ceplene® (histamine dihydrochloride) for the remission maintenance of acute myeloid leukemia (AML) patients in first complete remission. Health Canada's performance target for the completion of review and a decision is within 300 days.
Published Studies Related to Mylotarg (Gemtuzumab Ozogamicin)
Gemtuzumab ozogamicin with or without interleukin 11 in patients 65 years of age or older with untreated acute myeloid leukemia and high-risk myelodysplastic syndrome: comparison with idarubicin plus continuous-infusion, high-dose cytosine arabinoside. [2002.06.15]
We investigated treatment with gemtuzumab ozogamicin (GO) in 51 patients aged 65 years or older with newly diagnosed acute myeloid leukemia (AML), refectory anemia (RA) with excess of blasts in transformation, or RA with excess blasts. GO was given in doses of 9 mg/m(2) of body-surface area on days 1 and 8 or, therapeutically equivalently, on days 1 and 15, with or without interleukin 11 (IL-11; 15 microg/kg per day on days 3 to 28), with assignment to IL-11 treatment made randomly...
Gemtuzumab ozogamicin (GO) in relapsed/refractory patients with acute myeloid leukemia. [2009.07]
OBJECTIVE: Gemtuzumab ozogamicin (GO) is a humanized anti-CD33 antibody, linked to calicheamicin, which has been approved in Japan recently. We conducted to evaluate the efficacy and toxicity of GO in our patients with relapsed or refractory AML retrospectively... CONCLUSION: GO is a valuable new treatment option for relapsed or refractory AML patients, however, the benefit from single agent appears insufficient. On going clinical trials including combination with other antileukemic agents might better define the role of GO.
Phase I/II study of humanized anti-CD33 antibody conjugated with calicheamicin, gemtuzumab ozogamicin, in relapsed or refractory acute myeloid leukemia: final results of Japanese multicenter cooperative study. [2009.05]
The primary objective of this study was to investigate the tolerability, efficacy and pharmacokinetic profile of gemtuzumab ozogamicin (GO) in patients with relapsed and/or refractory CD33-positive acute myeloid leukemia (AML). Patients received 2-h infusions of GO twice with an interval of approximately 14 days...
Effective treatment of acute promyelocytic leukemia with all-trans-retinoic acid, arsenic trioxide, and gemtuzumab ozogamicin. [2009.02.01]
PURPOSE: We examined the outcome of patients with newly diagnosed acute promyelocytic leukemia (APL) treated with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) with or without gemtuzumab ozogamicin (GO) but without traditional cytotoxic chemotherapy... CONCLUSION: The combination of ATRA and ATO (with or without GO) as initial therapy for APL was effective and safe and can substitute chemotherapy-containing regimens.
Successful treatment with gemtuzumab ozogamicin monotherapy in a pediatric patient with resistant relapse of acute myeloid leukemia. [2009.01]
There are few therapeutic options in relapsed or refractory acute myeloid leukemia patients.Herein, we present a 15-year-old acute myeloid leukemia patient who was resistant at relapse and could achieve remission with gemtuzumab ozogamicin at a total dose of 9 mg/m2, divided into three doses and delivered to hematopoietic stem-cell transplantation; however, the patient relapsed in a short time without application of transplantation.
Clinical Trials Related to Mylotarg (Gemtuzumab Ozogamicin)
Study Evaluating the Effect of Corticosteroids on Mylotarg® Infusion-Related Adverse Events in Patients With Leukemia [Completed]
The purpose of this study is to evaluate the effect of corticosteroids on the frequency and
severity of Mylotarg® infusion–related adverse events, to evaluate the effect of
corticosteroids on the efficacy of Mylotarg® induced complete response (CR) and complete
response with incomplete platelet recovery (CRp) at one-month post treatment.
Study Evaluating Mylotarg (Gemtuzumab Ozogamicin) in Usual Care [Completed]
Mylotarg and Ara-C in Untreated Patients Above 60 Years With AML and High-Risk MDS [Active, not recruiting]
The purpose of this study is to find out how safe and effective the combination of Mylotarg
in combination with cytarabine is in treating patients with Acute Myeloid Leukemia and
advanced Myelodysplastic Syndrome over the age of 60 years.
Nonmyeloablative Preparative Regimen Using Mylotarg for Patients With High Risk Acute Myeloid Leukemia (AML), Acute Lymphocytic Leukemia (ALL), Chronic Myeloid Leukemia (CML) and Myelodysplastic Syndrome (MDS) [Terminated]
Primary Objective: To determine the safety and maximum tolerated dose of CMA-676 as part of
an intensive but nonmyeloablative preparative regimen in older or medically infirm patients
undergoing mini-allogeneic peripheral blood stem cell transplantation
Secondary Objectives:
1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with
this strategy.
2. To evaluate disease-free and overall survival and relapse rates.
3. To evaluate the need and ability to give multiple cycles of Mylotarg plus FA and
mobilized DLI in patients not achieving complete remission.
Allo Transplantation With Mylotarg, Fludarabine and Melphalan for AML, CML and MDS. [Completed]
Primary Objective:
1. To determine the safety and maximum tolerated dose of Mylotarg as part of a
reduced-intensity preparative regimen patients undergoing related, mismatched-related or
matched unrelated donor transplantation.
Secondary Objectives:
1. To evaluate response rates, engraftment kinetics and degree of chimerism achievable with
this strategy.
2. To evaluate the incidence and severity of GVHD in this population
3. To evaluate disease-free and overall survival and relapse rates.
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Page last updated: 2009-11-10
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