FDA Expands Methotrexate Approval for Pediatric Acute Lymphoblastic Leukemia
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The FDA has expanded the approval of methotrexate (Jylamvo) to include pediatric patients with acute lymphoblastic leukemia (search) (ALL (search)) as part of a combination chemotherapy maintenance regimen.
The recommended starting dose for methotrexate in pediatric ALL (search) is 20 mg/m2 once weekly, with regular monitoring of absolute neutrophil counts and platelet counts for dose adjustments.
This approval provides a patient-friendly alternative for pediatric patients, addressing unmet needs in oncology and autoimmune diseases, according to Shorla Oncology (search)'s CEO.
The FDA has broadened the approval of methotrexate (Jylamvo) to encompass the treatment of pediatric patients diagnosed with acute lymphoblastic leukemia (search) (ALL (search)) and polyarticular juvenile idiopathic arthritis. This regulatory decision marks a significant advancement in pediatric oncology, offering a more convenient treatment option for young patients battling ALL.
The recommended starting dose of methotrexate in ALL (search) is 20 mg/m2 administered once weekly, as an integral component of a combination chemotherapy maintenance regimen. Following drug administration, vigilant monitoring of absolute neutrophil counts (ANCs) and platelet counts is crucial, with dose adjustments implemented to sustain ANC at the desired level. This personalized approach ensures optimal therapeutic efficacy while minimizing potential adverse effects.
"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," stated Sharon Cunningham, chief executive officer of Shorla Oncology (search), in a news release. "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."
In November 2022, the FDA initially approved methotrexate as the sole oral liquid formulation for various indications, including:
- Combination chemotherapy maintenance in adults with ALL
- Monotherapy or combination chemotherapy in adults with mycosis fungoides (cutaneous T-cell lymphoma)
- Metronomic combination chemotherapy in adults with relapsed or refractory non-Hodgkin lymphoma
- Adults with rheumatoid arthritis
- Adults with severe psoriasis
This expanded approval underscores the versatility and clinical utility of methotrexate in managing a spectrum of oncologic and autoimmune conditions across different age groups.