FDA Expands Approval for Jylamvo Oral Methotrexate Solution in ALL

• The FDA has expanded the approval for Jylamvo, an oral methotrexate solution, to include pediatric patients with acute lymphoblastic leukemia (ALL).
• Jylamvo was the first oral methotrexate solution approved for the treatment of adult patients with ALL, mycosis fungoides, and relapsed/refractory non-Hodgkin lymphoma.
• Jylamvo is now the only oral methotrexate solution available for both adult and pediatric indications.

Jylamvo has gained expanded approval from the FDA to include the treatment of pediatric ALL, making it the only oral methotrexate solution available for adult and pediatric patients.¹

“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, in a press release. “We are pleased to offer a convenient, patient-friendly alternative for both adult and pediatric patients in the US as we continue to develop innovative solutions for those with limited treatment options.”

The expanded approval also includes treatment of pediatric patients with polyarticular juvenile idiopathic arthritis.

In November 2022, the FDA approved Jylamvo for the treatment of adult patients with ALL, mycosis fungoides, and relapsed/refractory non-Hodgkin lymphoma, as well as rheumatoid arthritis and severe psoriasis.^1,2

Jymlavo offers advantages over traditional methotrexate formulations, including room temperature stability for 3 months after opening.¹

In June 2024, the FDA approved Shorla Oncology’s Tepylute (SH-105), a ready-to-dilute formulation of a treatment for breast and ovarian adenocarcinoma.³ The FDA is currently considering Shorla’s new drug application (NDA) of SH-201, the first palatable oral liquid of the related chemotherapeutic agent to treat various types of cancers.⁴ The FDA has set a Prescription Drug User Fee Act target action date of November 30, 2024, for the NDA.

REFERENCES:

1. 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. October 29, 2024. Accessed October 29, 2024. https://tinyurl.com/39mbr2vv

2. Jylamvo® (methotrexate) – New drug approval. OptumRx. November 29, 2022. Accessed October 29, 2024. https://tinyurl.com/477asa7t

3. Shorla Oncology announces FDA approval for TEPYLUTE, a novel formulation to treat breast and ovarian cancer. News release. Shorla Oncology. June 28, 2024. Accessed October 29, 2024. https://bit.ly/45Rdtko

4. Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukemia and other cancers. News release. Shorla Oncology. April 8, 2024. Accessed October 29, 2024. https://tinyurl.com/dbrczpjw