FDA Expands Approval of Methotrexate to Include Pediatric Acute Lymphoblastic Leukemia

FDA

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:

• As part of a combination chemotherapy maintenance regimen in adults with ALL
• As a monotherapy or part of a combination chemotherapy regimen in adults with mycosis fungoides (cutaneous T-cel lymphoma)
• As part of a metronomic combination chemotherapy regimen in adults with relapsed or refractory non-Hodgkin lymphoma
• Adults with rheumatoid arthritis
• Adults with severe psoriasis

References

1. Shorla Oncology announces US Food and Drug Administration (FDA) expanded approval of JYLAMVO™ (methotrexate), an oncology and autoimmune drug for pediatric indications. News release. Shorla Oncology. October 29, 2024. Accessed October 29, 2024.https://www.businesswire.com/news/home/20241029627376/en/
2. Jylamvo. Prescribing information. Shorla Oncology; 2024. Accessed October 29, 2024. https://shorlaoncology.com/pdf/Jylamvo_Final_Label.pdf
3. Jylamvo® (methotrexate) – new drug approval. Optum Rx. 2022. Accessed October 29, 2024. https://professionals.optumrx.com/content/dam/optum3/professional-optumrx/news/rxnews/drug-approvals/drugapproval_jylamvo_2022-1206.pdf