Shorla Oncology Announces FDA Approval of IMKELDI (imatinib) Oral Solution, an Oral Liquid for the Treatment of Certain Forms of Leukemia and Other Cancers
Shorla Oncology, (“Shorla”), a U.S.-Ireland specialty pharmaceutical company, announced today 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.
Sharon Cunningham, CEO, ShorlaWe are thrilled to offer an oral solution option for patients with leukemia 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.
Orlaith Ryan, CTO and Co-Founder, ShoralThis 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.
Rayna Herman, CCO, ShorlaAt Shorla, every innovation is driven by our commitment to put patients first. IMKELDI is another step forward as we continue to expand our growing portfolio with products that prioritize accessibility and affordability.
About IMKELDI
IMKELDI is an oral solution of imatinib mesylate, a tyrosine kinase inhibitor, approved by the U.S. Food and Drug Administration for use in certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia) and other cancers in adults and pediatric patients as young as one year old. Featuring a convenient, palatable strawberry flavor and a stable formulation that does not require refrigeration, IMKELDI offers a patient-friendly, precise treatment option designed to improve adherence and accessibility.
About Shorla Oncology
Shorla Oncology is a privately- held, U.S. and Ireland- based commercial stage specialty pharmaceutical company established by Sharon Cunningham and Orlaith Ryan. The company has an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers. Shorla is focused on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population. The company’s growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. Shorla currently markets two products, Nelarabine for the treatment of T-cell leukemia and JYLAMVO for the treatment of acute lymphoblastic leukemia and other indications.
For further information, please visit www.shorlaoncology.com.
Learn more about Shorla Oncology