FDA approves Shorla Oncology’s IMKELDI for certain leukaemia

The US Food and Drug Administration (FDA) has approved Shorla Oncology‘s IMKELDI to treat specific forms of leukaemia.

IMKELDI offers a liquid formulation of imatinib mesylate, a tyrosine kinase inhibitor. It is designed for use in adults and paediatric patients as young as one, targeting acute lymphoblastic leukaemia, chronic myeloid leukaemia, gastrointestinal stromal tumours and myelodysplastic syndrome/myeloproliferative disease.

Without requiring refrigeration, the strawberry-flavoured solution is intended to improve patient adherence and access to treatment. Its stable formulation aims to provide precise dosing.

Shorla Oncology CEO Sharon Cunningham stated: “We are thrilled to offer an oral solution option for patients with leukaemia and other cancers, a meaningful advancement for thousands in need.

“Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.”

The company announced the expanded FDA approval of JYLAMVO (methotrexate) in October 2024.

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JYLAMVO is approved for paediatric patients with acute lymphoblastic leukaemia (ALL) and polyarticular juvenile idiopathic arthritis, making it the sole oral liquid methotrexate approved for both adult and paediatric use.

In July 2024, the FDA approved a new drug application (NDA) for TEPYLUTE to treat breast and ovarian cancer.

Shorla Oncology co-founder and chief technical officer Orlaith Ryan stated: “This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation.

“Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”

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