FDA Expands Jylamvo Approval for Pediatric Acute Lymphoblastic Leukemia
Key Insights
The FDA has expanded the approval of Jylamvo, an oral methotrexate solution, to include pediatric patients with acute lymphoblastic leukemia (search) (ALL).
Jylamvo is now the only oral methotrexate solution available for both adult and pediatric indications, offering a convenient alternative.
This approval marks a significant advancement in addressing the unmet needs of pediatric care in oncology and autoimmune diseases.
The U.S. Food and Drug Administration (FDA) has broadened the approval for Jylamvo (methotrexate), an oral solution, to encompass the treatment of pediatric patients with acute lymphoblastic leukemia (search) (ALL). This expansion makes Jylamvo the sole oral methotrexate option available for both adult and pediatric use in this indication.
Jylamvo, developed by Shorla Oncology (search) Inc., is a folate analog metabolic inhibitor. It is now indicated for use in combination chemotherapy maintenance regimens for both adult and pediatric patients with ALL. The initial approval in November 2022 covered adult patients with ALL, mycosis fungoides (search), and relapsed or refractory non-Hodgkin lymphoma (search), as well as rheumatoid arthritis (search) and severe psoriasis (search).
According to Shorla Oncology (search), this expanded approval addresses critical unmet needs in pediatric oncology and autoimmune disease care, providing a more convenient, patient-friendly alternative. Sharon Cunningham, CEO of Shorla Oncology, stated, "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."
In addition to ALL, the expanded approval includes the treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (search) (pJIA). Jylamvo offers the advantage of room temperature stability for up to three months after opening, simplifying storage and handling.
Shorla Oncology (search) continues to develop innovative solutions for patients with limited treatment options. The FDA recently approved their Tepylute (SH-105) for breast and ovarian adenocarcinoma in June 2024. The agency is also reviewing Shorla’s new drug application (NDA) for SH-201, an oral liquid formulation of a chemotherapeutic agent, with a target action date of November 30, 2024.