FDA Approves Oral Formulation of Imatinib for Patients With Certain Leukemias and Gastrointestinal Tumors
On November 25th, 2024, the US Food and Drug Administration (FDA) approved an advanced liquid formulation of imatinib for patients with certain cancers including chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disease (MPD), and gastrointestinal tumors. This new formulation may improve dosing accuracy and adherence, particularly for patients who have difficulty swallowing or who may need a dose tailored for body surface area.
The most common adverse events reported in ≥30% of patients included edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain. The most common hematological toxicities included anemia, neutropenia, and thrombocytopenia.
Imatinib is prescribed as an 80 mg/mL oral solution that should be measured with an appropriate press-in bottle adapter and oral dispensing syringe. The recommended dosage of imatinib is 300 mg to 800 mg based on cancer type, administered once or twice daily with a meal and a large glass of water. Dose reductions are permitted for patients who experience moderate to severe renal impairment.
Source:
Shorla oncology announces FDA approval of IMKELDI (imatinib) oral solution, an oral liquid for the treatment of certain forms of leukemia and other cancers. Accessed November 25, 2024. https://www.businesswire.com/news/home/20241125044117/en/Shorla-Oncology-Announces-FDA-Approval-of-IMKELDI-imatinib-Oral-Solution-an-Oral-Liquid-for-the-Treatment-of-Certain-Forms-of-Leukemia-and-Other-Cancers
IMKELDI (imatinib) oral solution prescribing highlights. Accessed on November 25, 2024. https://shorlaoncology.com/pdf/Imkeldi_PrescribingInformation.pdf
