FDA extends Jylamvo approval to pediatric ALL, pJIA

This week, Shorla Oncology announced that FDA expanded approval of liquid methotrexate (Jylamvo) to include the treatment of pediatric patients with acute lymphoblastic leukemia (ALL) or polyarticular juvenile idiopathic arthritis (pJIA).

Jylamvo's safety and effectiveness in pediatric patients with ALL or pJIA were based on clinical trial data using other methotrexate formulations. The drug was initially approved for use in adults with ALL, mycosis fungoides, non-Hodgkin lymphomas, rheumatoid arthritis, and severe psoriasis.

Sources:

Shorla Oncology. (2024, October 29). Shorla Oncology Announces U.S. Food and Drug Administration (FDA) Expanded Approval of JYLAMVO™ (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications. [News release]. https://shorlaoncology.com/shorla-oncology-announces-u-s-food-and-drug-administration-fda-expanded-approval-of-jylamvo-methotrexate-an-oncology-and-autoimmune-drug-for-pediatric-indications/

Shorla Oncology. (2024, October 29). Jylamvo prescribing information. https://shorlaoncology.com/pdf/Jylamvo_Final_Label.pdf.