On November 25, the Food and Drug Administration (FDA) approved Imkeldi, an oral solution of imatinib, to treat certain types of leukemia and other cancers.
In 2001, the FDA approved the original tablet formulation of imatinib, sold as Gleevec, which dramatically improved survival for people with leukemia. What’s more, the drug is credited with transforming the oncology field by ushering in targeted therapies, which work against cancer cells with specific gene mutations or other unique characteristics.
Like Gleevec, Imkeldi is approved for the treatment of several cancers and related conditions, including chronic myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic/myeloproliferative disease and gastrointestinal stromal tumors.
The liquid formulation allows for more precise dosing and may be helpful for young children, people with advanced disease and disabled people who have difficulty swallowing pills.
“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation reinnovation,” Shorla Oncology cofounder and chief technical officer Orlaith Ryan said in a news release. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”
Click here for full prescribing information for Imkeldi.
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