Imkeldi (Imatinib): Shorla Oncology Adds Another Accessible Solution to Its Leukemia Pipeline

Shorla Oncology has received US Food and Drug Administration (FDA) approval for Imkeldi, an oral solution of imatinib designed to treat specific forms of leukemia and other cancers. Imkeldi introduces an accessible alternative to traditional tablets, particularly for those who struggle with swallowing or require customized dosing.

Imkeldi’s innovative formulation provides consistent dosing accuracy while offering a palatable strawberry flavor and stable storage without refrigeration.

The approval marks the fourth drug in Shorla’s expanding oncology portfolio, following Tepylute, a ready-to-dilute injectable formulation of the chemotherapy agent thiotepa. Approved earlier this year, Tepylute eliminates the need for reconstitution, simplifying preparation and ensuring accurate dosing for breast and ovarian cancer patients. The drug also reduces exposure risks for healthcare workers by improving handling safety in oncology clinics.

Imkeldi works by targeting tyrosine kinases — enzymes that promote uncontrolled cell growth in cancers. By blocking these enzymes, the drug slows or halts disease progression in conditions such as chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome and gastrointestinal stromal tumors. These cancers affect thousands of patients annually in the US, making Imkeldi’s approval a meaningful step forward in addressing unmet treatment needs.

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In the company’s news release, Orlaith Ryan, Shorla’s chief technical officer and co-founder, called the approval a significant milestone, emphasizing the company’s mission to reimagine existing therapies to improve accessibility and outcomes.

Sharon Cunningham, Shorla’s CEO, highlighted the critical role of formulations like Imkeldi in improving adherence and treatment outcomes, underscoring Shorla’s dedication to affordability and innovation in oncology care.

Imkeldi’s approval follows the recent FDA expansion of Jylamvo, an oral liquid methotrexate solution, now approved for pediatric and adult patients with acute lymphoblastic leukemia and polyarticular juvenile idiopathic arthritis. As the only oral liquid methotrexate on the market, Jylamvo offers a convenient, orange-flavored formulation with room temperature stability for up to 90 days, eliminating the need for compounding or refrigeration. With the leukemia therapeutics market projected to double by 2032 — driven by rising cases and breakthroughs like CAR T-cell therapies and targeted immune treatments — Shorla Oncology’s focus on innovative, patient-friendly formulations like Imkeldi and Jylamvo highlights its commitment to addressing unmet needs.