FDA Approves Imkeldi by Shorla Oncology for Leukaemia and Other Cancers

The US Food and Drug Administration (FDA) has sanctioned Shorla Oncology’s Imkeldi oral solution for the treatment of certain forms of leukaemia and other cancers in both adults and children as young as one year. Imkeldi represents an advanced liquid formulation of the tyrosine kinase inhibitor imatinib mesylate, designed to slow or inhibit the growth of cancers such as chronic myeloid leukaemia (CML), acute lymphoblastic leukaemia (ALL), gastrointestinal stromal tumours (GIST), and myelodysplastic syndrome/myeloproliferative disease (MDS/MPD).

In the United States, it is estimated that 9,280 individuals will be diagnosed with CML, up to 6,000 with GIST, and over 10,000 with MDS/MPD this year. Despite the clinical benefits of imatinib, Shorla has highlighted patient adherence as a potential issue, pointing to the importance of a more accessible and patient-friendly oral solution.

Imkeldi is strawberry-flavored and does not need refrigeration, which Shorla hopes will improve both adherence and accessibility. Shorla’s chief executive officer, Sharon Cunningham, expressed enthusiasm about the FDA’s decision, stating, “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.”

This approval comes just a month after the FDA approved Shorla’s Jylamvo, intended for treating paediatric patients with ALL and polyarticular juvenile idiopathic arthritis, making it the only oral liquid methotrexate approved for both adult and paediatric populations. At the time of this announcement in October, Cunningham remarked, “This approval follows Jylamvo’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of paediatric care in oncology and autoimmune diseases.”

Additionally, in July, the FDA approved Shorla’s Tepylute, a ready-to-dilute liquid formulation of thiotepa for the treatment of breast and ovarian cancer. This formulation eliminates the need for complex and time-consuming reconstitution, allowing for ‘just in time’ preparation.