FDA Expands Approval of JYLAMVO (Methotrexate) for Pediatric ALL and pJIA
Key Insights
The FDA has expanded the approval of JYLAMVO (methotrexate) to include 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 to pills.
The approval addresses unmet needs in pediatric oncology and autoimmune diseases, providing an easy-to-administer, palatable option for patients.
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 makes JYLAMVO the only oral liquid methotrexate on the market approved for both adult and pediatric indications.
Sharon Cunningham, chief executive officer of Shorla Oncology (search), 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. We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the U.S. as we continue to develop innovative solutions for those with limited treatment options."
JYLAMVO: Convenient and Palatable Option
JYLAMVO, an anti-inflammatory and cancer oral methotrexate solution, is now approved for use in both adult and pediatric patients with rheumatological, dermatological, and oncological diseases. The orange-flavored solution eliminates the need for crushing or splitting pills, or compounding into a liquid formulation, making it easier to administer. It also offers the advantage of remaining stable at room temperature (68°F to 77°F) for 90 days, removing the need for cold chain storage pre-dispense.
Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology (search), noted, "For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills. At Shorla, we are committed to continuity of supply of age-appropriate formulations for patients in need."
Key Advantages of JYLAMVO
Rayna Herman, chief commercial officer of Shorla Oncology (search), 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. We are excited to expand our portfolio of innovative therapies for underserved patient populations."
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 disease. 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. The medication should be withheld or discontinued as appropriate.
Adverse Reactions and Drug Interactions
Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Clinically relevant adverse reactions also include infection, malaise, fatigue, chills, fever, and dizziness. Coadministration with certain drugs, such as oral antibiotics and nonsteroidal anti-inflammatory drugs, may increase methotrexate plasma concentrations, potentially increasing the risk of severe adverse reactions. Nitrous oxide anesthesia should be avoided in patients receiving methotrexate due to its potential to potentiate methotrexate's effects on folate-dependent metabolic pathways.