The U.S. Food and Drug Administration (FDA) announced the approval of imatinib (Imkeldi) oral solution, the first oral liquid formulation of the drug to treat certain types of leukemias and other cancers.
Background
In 2024, an estimated 9,280 patients will be diagnosed with chronic myeloid leukemia (CML), more than 10,000 patients will be diagnosed with myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), and up to 6,000 patients will be diagnosed with gastrointestinal tumors in the United States.
Despite the proven clinical benefits of imatinib, patient adherence can be challenging, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system.
“We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” emphasized Sharon Cunningham, MBA, Chief Executive Officer of the drug’s manufacturer, Shorla Oncology. “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,” she continued.
“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation reinnovation,” emphasized Orlaith Ryan, MSc, Chief Technical Officer and co-founder of Shorla Oncology. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer,” she added.
