FDA approves Imkeldi (imatinib) oral solution to treat Leukemias/MDS/MPD and GIST
Shorla Oncology ’ a U.S.-Ireland specialty pharmaceutical company, announced that the FDA has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers
Leveraging Shorla's novel technology, Imkeldi is an advanced liquid formulation of imatinib designed to provide dosing accuracy. Imkeldi can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST).
In 2024, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD, and up to 6,000 with GIST in the U.S. Despite the proven clinical benefits of imatinib, patient adherence can be an issue, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system.
“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”
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