FDA Expands Methotrexate Approval for Pediatric ALL and pJIA with JYLAMVO Oral Solution
核心洞察
The FDA has expanded the approval of methotrexate (JYLAMVO) for pediatric patients with acute lymphoblastic leukemia (搜索) (ALL) and polyarticular juvenile idiopathic arthritis (搜索) (pJIA).
JYLAMVO, developed by Shorla Oncology (搜索), is now the only approved oral liquid methotrexate for both adult and pediatric patients for these conditions.
This approval addresses unmet needs by offering a convenient, palatable option for pediatric patients who may have difficulty swallowing pills.
The FDA has granted expanded approval for methotrexate (JYLAMVO; Shorla Oncology (搜索)) to include pediatric patients with acute lymphoblastic leukemia (搜索) (ALL) and polyarticular juvenile idiopathic arthritis (搜索) (pJIA). This makes JYLAMVO the only approved oral liquid methotrexate available for both adult and pediatric patients, according to a press release from Shorla Oncology.
JYLAMVO, an orange-flavored oral liquid methotrexate, was initially approved for adults with acute lymphoblastic leukemia (搜索), mycosis fungoides (搜索), relapsed or refractory non-Hodgkin lymphoma (搜索), rheumatoid arthritis (搜索), and severe psoriasis (搜索). The expanded approval now allows its use in pediatric ALL and pJIA, providing a convenient alternative to traditional pill forms.
Benefits of Liquid Formulation
The liquid formulation of methotrexate eliminates the need for crushing or splitting pills, or compounding into a liquid formulation, which can be particularly beneficial for pediatric patients who have difficulty swallowing. The solution is stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage before dispensing, simplifying logistics for pharmacies and healthcare providers.
Management Perspectives
"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," said Sharon Cunningham, CEO of Shorla Oncology (搜索). "We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the United States as we continue to develop innovative solutions for those with limited treatment options."
Orlaith Ryan, chief technical officer and co-founder of Shorla Oncology (搜索), added, "For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills."
Indications and Contraindications
Methotrexate, a folate analog metabolic inhibitor, is now indicated for:
- Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
- Treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen.
- Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen.
- Treatment of adults with rheumatoid arthritis.
- Treatment of adults with severe psoriasis.
- Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA).
Methotrexate is contraindicated in pregnant women with non-neoplastic disease and in individuals with a history of severe hypersensitivity reactions to methotrexate. Standard warnings associated with methotrexate use apply.