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The FDA has expanded the approval of methotrexate to include use in pediatric patients with acute lymphoblastic leukemia.
The FDA has expanded the approval of methotrexate (Jylamvo) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis.1
The recommended starting dose of the agent in ALL is 20 mg/m2 once weekly, as part of a combination chemotherapy maintenance regimen.2 After the drug is given, absolute neutrophil counts (ANCs) and platelet counts must be monitored periodically and the dose should be adjusted to maintain ANC at a desired level.
“This approval follows Jylamvo's successful use in adult patients and represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases,” Sharon Cunningham, chief executive officer of Shorla Oncology, stated in a news release.1 “We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S. as we continue to develop innovative solutions for those with limited treatment options.”
Previously, in November 2022,3 the regulatory agency first approved the agent as the only oral liquid methotrexate for use in:
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