FDA

FDA approves first oral liquid formulation of imatinib

November 27, 2024

Brand name: Imkeldi

Generic name: imatinib

Manufacturer: Shorla Oncology

Approval date: November 22, 2024

Imkeldi (imatinib) is indicated for the treatment of chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), myelodysplastic/myeloproliferative diseases (MDS/MPD), and gastrointestinal stromal tumors (GIST) as well as aggressive systematic mastocytosis (ASM), hypereosinophilic syndrome (HES), chronic eosinophilic leukemia (CEL), and dermatofibrosarcoma protuberans (DFSP).

According to a manufacturer’s press release, Imkeldi is an advanced liquid formulation of imatinib designed to optimize dosing accuracy.

Safety

The most frequently reported adverse reactions (≥30%) are edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.

Recommended dose

Recommended dosage of Imkeldi varies by indication. According to the Prescribing Information, it’s important that Imkeldi be measured with an accurate measuring device. A household teaspoon is not an accurate measuring device.

Sources:

Shorla Oncology. (2024, November 25). Shorla Oncology Announces FDA Approval of IMKELDI (imatinib) Oral Solution, an Oral Liquid for the Treatment of Certain Forms of Leukemia and Other Cancers. [Press release]. 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

Shorla Oncology: Imkelda (imatinib) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219097s000lbl.pdf