FDA approves Imkeldi, imatinib as oral liquid, for certain leukemias
Strawberry-flavored liquid can help to treat specific forms of ALL, CML
The U.S. Food and Drug Administration (FDA) has approved an oral liquid formulation of imatinib, now called Imkeldi, to treat specific forms of acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML), among other cancers, including rare cancers.
As the first oral liquid form of imatinib, it offers a more precise treatment option to help improve therapy adherence and accessibility. It comes as a palatable strawberry-flavored solution that doesn’t need refrigeration, according to Shorla Oncology, the formulation’s developer.
“We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” Sharon Cunningham, Shorla Oncology’s CEO, said in a company press release.
“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,” Cunningham added.
Imkeldi, like imatinib, now may treat forms of Ph+ ALL and Ph+ CML
Leukemia is a group of blood cancers that usually begins in the bone marrow, and is marked by the excessive production of abnormal blood cells. Due to a lack of healthy blood cells, symptoms include bleeding and bruising, bone pain, fatigue, fever, and a higher risk of infections. Its four main types are ALL, CML, chronic lymphocytic leukemia (CLL), and acute myeloid leukemia (AML).
Imkeldi specifically was approved by the FDA to treat adults with relapsed or treatment-resistant (refractory) Philadelphia chromosome positive ALL ( Ph+ ALL), and children newly diagnosed with Ph+ ALL in combination with chemotherapy. It was approved for adults and children with Philadelphia chromosome positive CML (Ph+ CML), if the disease is in a chronic phase. It also can treat Ph+ CML in certain other phases or during a given crisis, the regulatory agency noted.
Imkeldi’s active ingredient is imatinib mesylate, a small molecule that blocks the activity of a group of enzymes called tyrosine kinases. These enzymes drive the growth of abnormal blood cells in leukemia.
The FDA approved imatinib in 2001 as an oral tablet (brand name Gleevec, generics available) to treat certain forms of leukemia, including Ph+ ALL and Ph+ CML, and other cancers in adults and children as young as 1 year old.
Despite its established clinical benefits, studies demonstrate a lack of adherence to imatinib, “underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system,” the company stated in its release.
Imkeldi is a liquid formulation of imatinib designed to improve dosing accuracy, treatment adherence and treatment accessibility. It comes as a concentrated solution containing 80 mg/mL of imatinib in a child-resistant bottle. Once opened, it’s stable at room temperature for up to 30 days, according to its FDA label.
Recommended doses vary according to the type of cancer Imkeldi is being used to treat.
Other cancers, or their specific forms, that Imkeldi may treat include myeloproliferative neoplasms, gastrointestinal stromal tumors, aggressive and systematic mastocytosis, hypereosinophilic syndrome, chronic eosinophilic leukemia, dermatofibrosarcoma protuberans.
“Our [company’s] mission to make existing oncology treatments better through formulation re-innovation,” said Orlaith Ryan, chief technical officer and co-founder of Shorla.
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