Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, 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 (ALL) and polyarticular juvenile idiopathic arthritis (pJIA). JYLAMVO is now the only oral liquid methotrexate on the market approved for both adult and pediatric indications.
Sharon Cunningham, chief executive officer 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."
JYLAMVO's Existing Approvals
JYLAMVO was initially approved by the FDA as an oral liquid methotrexate for treating adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis.
Formulation and Benefits
JYLAMVO features an orange flavor and is supplied with a dedicated dosing syringe. Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology, noted, "For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills."
Rayna Herman, chief commercial officer of Shorla Oncology, highlighted additional benefits: "In addition to its palatable formulation, JYLAMVO offers key differences over similar drugs, such as room temperature stability for three months after opening, which eliminates the need for refrigeration before dispensing and adds convenience for patients."
Important Safety Information
JYLAMVO carries a boxed warning regarding embryo-fetal toxicity, hypersensitivity reactions, and severe adverse reactions. Methotrexate can cause embryo-fetal toxicity, and JYLAMVO is contraindicated in pregnant women with non-neoplastic diseases. Serious adverse reactions, including death, have been reported with methotrexate, necessitating close monitoring for infections and adverse reactions affecting the bone marrow, gastrointestinal tract, liver, lungs, skin, and kidneys.
Contraindications
JYLAMVO is contraindicated in pregnant women with non-neoplastic disease and in patients with a history of severe hypersensitivity reactions to methotrexate, including anaphylaxis.
Warnings and Precautions
Warnings and precautions include embryo-fetal toxicity, hypersensitivity reactions, myelosuppression, gastrointestinal toxicity, hepatotoxicity, pulmonary toxicity, dermatologic reactions, renal toxicity, risk of serious adverse reactions with medication error, folic acid supplementation considerations, serious infections, neurotoxicity, secondary malignancies, tumor lysis syndrome, immunization risks, infertility, and increased risk of adverse reactions due to third-space accumulation.
