FDA Expands Approval of Jylamvo (Methotrexate) for Pediatric ALL and pJIA
Key Insights
The FDA has expanded the approval of Jylamvo (methotrexate) for pediatric patients with acute lymphoblastic leukemia (search) (ALL) and polyarticular juvenile idiopathic arthritis (search) (pJIA).
Jylamvo is now the only oral liquid methotrexate approved for both adult and pediatric indications, offering a convenient alternative for patients who have difficulty swallowing pills.
Jylamvo offers key advantages, including room temperature stability for three months after opening, eliminating the need for refrigeration before dispensing, adding convenience for patients.
Shorla Oncology (search) announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of Jylamvo (methotrexate) to include the treatment of pediatric patients with acute lymphoblastic leukemia (search) (ALL) and polyarticular juvenile idiopathic arthritis (search) (pJIA). This approval marks Jylamvo as the only oral liquid methotrexate on the market approved for both adult and pediatric indications.
Addressing Unmet Needs in Pediatric Care
According to Sharon Cunningham, chief executive officer of Shorla Oncology (search), 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 company is pleased to offer a patient-friendly alternative for both adult and pediatric patients in the U.S., as they continue to develop innovative solutions for those with limited treatment options.
Jylamvo's Existing Approvals and Advantages
Jylamvo was initially approved by the FDA as the only oral liquid methotrexate for treating adults with acute lymphoblastic leukemia (search), mycosis fungoides (search), relapsed or refractory non-Hodgkin lymphoma (search), rheumatoid arthritis (search), and severe psoriasis (search). The formulation, which features an orange flavor and comes with a dedicated dosing syringe, is designed to be easy to administer, eliminating the need for crushing or splitting pills, or compounding into a liquid formulation.
Formulation Benefits
Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology (search), highlighted that Jylamvo offers a convenient, palatable option for patients, including those with chronic conditions like cancer, who may have difficulty swallowing pills. The company is committed to ensuring a consistent supply of age-appropriate formulations for patients in need.
Key Differences Over Similar Drugs
Rayna Herman, chief commercial officer of Shorla Oncology (search), noted that Jylamvo offers key differences over similar drugs, such as room temperature stability for three months after opening. This eliminates the need for refrigeration before dispensing, adding convenience for patients. The company is excited to expand its portfolio of innovative therapies for underserved patient populations.
About Jylamvo
Jylamvo is an anti-inflammatory and cancer oral methotrexate solution approved by the U.S. Food and Drug Administration for use in adult and pediatric patients with rheumatological, dermatological, and oncological diseases. It remains stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage pre-dispense.