Supplemental approval from the FDA for Jylamvo (methotrexate) to treat ALL and polyarticular juvenile idiopathic arthritis – Shorla Oncology

Shorla Oncology , a U.S.-Ireland specialty pharmaceutical company, announced that the 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).

With this approval, Jylamvo is currently the only oral liquid methotrexate on the market approved for both adult and pediatric indications. “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, chief executive officer of Shorla Oncology. “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 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.