FDA/CDC

FDA reapproves gemtuzumab ozogamicin for CD33-positive AML treatment


 

The Food and Drug Administration has approved gemtuzumab ozogamicin (Mylotarg) for the treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults, according to a press release.

Approval was based on results from three clinical trials. In the first, newly diagnosed AML patients who received gemtuzumab ozogamicin plus chemotherapy had significantly longer event-free survival than did patients who received chemotherapy alone. In a second trial, patients who received gemtuzumab ozogamicin alone had better overall survival compared to those who received only best supportive care. In the third clinical trial, 26% of patients who had experienced a relapse and received gemtuzumab ozogamicin experienced a remission.

Initial approval for gemtuzumab ozogamicin was granted in May 2000 as a stand-alone treatment for CD33-positive AML in older patients, but was withdrawn from the market after clinical trials failed to find any benefit and health concerns were noted. The current approval is based on a lower dosage, a more expansive patient population, and a schedule in combination with chemotherapy.

Common side effects of gemtuzumab ozogamicin include fever, nausea, infection, vomiting, bleeding, thrombocytopenia, stomatitis, constipation, rash, headache, elevated liver function tests, and neutropenia; it is not recommended for women who are pregnant or breastfeeding.

Gemtuzumab ozogamicin was also approved to treat patients older than 2 years old who have experienced a relapse or have not responded to initial treatment.

“Mylotarg’s history underscores the importance of examining alternative dosing, scheduling, and administration of therapies for patients with cancer, especially in those who may be most vulnerable to the side effects of treatment,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, said in the press release.

Recommended Reading

Hospice care underused in older patients with de novo AML
MDedge Hematology and Oncology
Enasidenib data in IDH2-mutated AML are basis for combination therapy trials
MDedge Hematology and Oncology
Vitamin C regulates HSCs, curbs AML development
MDedge Hematology and Oncology
Antibody could treat AML, MM, and NHL
MDedge Hematology and Oncology
FDA grants drug orphan designation for AML
MDedge Hematology and Oncology
FDA grants drug orphan designation for AML, CMML
MDedge Hematology and Oncology
VSTs can treat 5 different viral infections after HSCT
MDedge Hematology and Oncology
Strategy could reduce myelosuppression in AML
MDedge Hematology and Oncology
Targeting heme synthesis to treat AML
MDedge Hematology and Oncology
FDA approves drug to treat 2 types of AML
MDedge Hematology and Oncology