FDA Expands Approval of Shorla Oncology's JYLAMVO for Pediatric Use
Key Insights
The FDA has granted expanded approval to Shorla Oncology (search)’s JYLAMVO (methotrexate) for pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (search) (pJIA).
JYLAMVO, an orange-flavored liquid methotrexate solution, offers a convenient and patient-friendly alternative for both adult and pediatric patients, eliminating the need for cold chain storage.
This approval marks a significant advancement in addressing the unmet needs of pediatric care in oncology and autoimmune diseases, providing an easier-to-administer option with a dosing syringe.
The U.S. Food and Drug Administration (FDA) has expanded the approval for Shorla Oncology (search)’s JYLAMVO (methotrexate) to include pediatric patients. This oral liquid formulation of methotrexate is now indicated for the treatment of children with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (search) (pJIA). The approval aims to address the unmet needs in pediatric oncology and autoimmune disease care by providing a more convenient and patient-friendly alternative to traditional formulations.
JYLAMVO is presented as an orange-flavored liquid solution, designed for ease of administration with an included dosing syringe. Notably, the drug maintains stability at room temperature (68°F to 77°F) for up to 90 days, removing the necessity for cold chain storage prior to dispensing. This feature simplifies handling and storage logistics for both healthcare providers and patients.
Addressing Unmet Needs in Pediatric Care
According to Shorla Oncology (search) CEO Sharon Cunningham, this approval represents a critical step forward in addressing the unmet needs of pediatric care in oncology and autoimmune diseases, building on JYLAMVO’s successful use in adult patients. The availability of a convenient, patient-friendly alternative is expected to improve treatment adherence and outcomes in pediatric populations.
Prior Approvals and Commercial Availability
JYLAMVO initially received FDA approval in 2022 for adult patients with ALL, mycosis fungoides (search), relapsed or refractory non-Hodgkin lymphoma (search), rheumatoid arthritis (search), and severe psoriasis (search). Shorla Oncology (search) acquired the U.S. rights to JYLAMVO from Therakind (search) in October of the previous year and commercially launched the product in the U.S. market in December 2023 in partnership with EVERSANA. The product also holds a European Union Centralised Licence since 2017 and is authorized for sale in several other countries.