Methotrexate gains expanded approval for pediatric acute lymphoblastic leukemia, polyarticular juvenile arthritis
The approval makes methotrexate, currently, the only only oral liquid methotrexate on the market approved for both adult and pediatric indications.
The FDA has approved an extended indication of methotrexate (JYLAMVO; Shorla Oncology) to include pediatric patients with acute lymphoblastic leukemia (ALL) and polyarticular juvenile idiopathic arthritis (pJIA), making it the only approved oral liquid methotrexate for both adult and pediatric patients, according to a press release from Shorla Oncology.
With a dedicated dosing syringe, the orange-flavored oral liquid methotrexate was first approved by the FDA as the only oral liquid methotrexate to treat adults with acute lymphoblastic leukemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis and severe psoriasis, stated Shorla.
The anit-inflammatory and cancer oral methotrexate solution is used in adult and pediatric patients with rheumatological, dermatological and oncological diseases and is stable at room temperature (68°F to 77°F) for 90 days and does not require cold chain storage pre-dispense. The liquid allows for the elimination of crushing or splitting pills, or compounding into a liquid formulation.
“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, Shorla Oncology in a statement. "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.”
“For patients with chronic conditions including cancer, JYLAMVO offers a convenient, palatable option for patients who may have difficulty swallowing pills,” added Orlaith Ryan, chief technical officer, co-founder, Shorla Oncology.
According to the pharmaceutical company, methotrexate a folate analog metabolic inhibitor indicated for the:
- 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 those with a history of severe hypersensitivity reactions to methotrexate, and includes the following warning.
Reference:
Shorla Oncology announces US FDA expanded approval of JYLAMVO (methotrexate), an oncology and autoimmune drug for pediatric indications. Shorla Oncology. Press release. October 29, 2024. Accessed October 29, 2024. https://www.businesswire.com/news/home/20241029627376/en/
