FDA Expands Approval of JYLAMVO for Pediatric Use in Oncology and Autoimmune Diseases

Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, has received expanded approval from the U.S. Food and Drug Administration (FDA) for JYLAMVO (methotrexate), now including the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). This approval positions JYLAMVO as the only oral liquid methotrexate on the market approved for both adult and pediatric indications.

Sharon Cunningham, CEO of Shorla Oncology, highlighted the significance of this approval, stating, "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." The company aims to provide a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S., continuing to develop innovative solutions for those with limited treatment options.

JYLAMVO, which features an orange flavor and comes with a dedicated dosing syringe, was first approved by the FDA for treating adults with various conditions, including acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis. Orlaith Ryan, CTO and co-founder of Shorla Oncology, emphasized the drug's convenience for patients who may have difficulty swallowing pills, stating, "JYLAMVO offers a convenient, palatable option for patients with chronic conditions including cancer."

Rayna Herman, CCO of Shorla Oncology, added that JYLAMVO offers key differences over similar drugs, such as room temperature stability for three months after opening, eliminating the need for refrigeration before dispensing and adding convenience for patients.

Important Safety Information includes warnings about embryo-fetal toxicity, hypersensitivity reactions, and severe adverse reactions. JYLAMVO is contraindicated in pregnant women with non-neoplastic disease and patients with a history of severe hypersensitivity reactions to methotrexate. The drug can cause serious adverse reactions, including death, and requires close monitoring for infections and adverse reactions affecting the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys.

Shorla Oncology is committed to developing innovative oncology drugs for orphan and pediatric cancers, focusing on indications where existing treatments are limited, in shortage, or inadequate for the target population. The company's portfolio aims to bring accessible, affordable, and life-saving treatments to patients, significantly contributing to patient care.