FDA Expands Methotrexate Approval for Pediatric ALL and Juvenile Idiopathic Arthritis
Key Insights
The FDA has expanded the approval of methotrexate (Jylamvo) to include pediatric patients with acute lymphoblastic leukemia (search) (ALL (search)).
The expanded approval also covers the use of methotrexate in pediatric patients with polyarticular juvenile idiopathic arthritis (search).
The recommended starting dose for ALL (search) is 20 mg/m2 weekly, as part of combination chemotherapy, with regular monitoring of blood counts.
The FDA has broadened the approval of methotrexate (Jylamvo) to encompass pediatric patients suffering from acute lymphoblastic leukemia (search) (ALL (search)) and polyarticular juvenile idiopathic arthritis (search). This decision, announced by Shorla Oncology (search), marks a significant advancement in pediatric care, providing a much-needed treatment option for these vulnerable populations.
The recommended starting dose of methotrexate for pediatric ALL (search) patients is 20 mg/m2 administered once weekly. This is intended for use as part of a combination chemotherapy maintenance regimen. Following administration, it is crucial to monitor absolute neutrophil counts (ANCs) and platelet counts regularly, adjusting the dosage to maintain the ANC at the desired level.
Addressing Unmet Needs
According to Sharon Cunningham, CEO of Shorla Oncology (search), "This approval follows [methotrexate'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." She further emphasized the company's commitment to providing convenient, patient-friendly alternatives for both adult and pediatric patients, as well as developing innovative solutions for those with limited treatment options.
Prior Approvals
In November 2022, the FDA initially approved methotrexate as the only 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