Imkeldi FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 26, 2024.

FDA Approved: Yes (First approved November 22, 2024)
Brand name: Imkeldi
Generic name: imatinib mesylate
Dosage form: Oral Solution
Company: Shorla Oncology Inc.
Treatment for: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Diseases, Myeloproliferative Disorders, Systemic Mastocytosis, Hypereosinophilic Syndrome, Chronic Eosinophilic Leukemia, Dermatofibrosarcoma Protuberans, Gastrointestinal Stromal Tumor

Imkeldi (imatinib mesylate) is an oral liquid formulation of the approved kinase inhibitor imatinib used for the treatment of certain forms of leukemia and other cancers.

• Imkeldi is indicated for the treatment of:
  - Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
  - Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy.
  - Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
  - Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
  - Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.
  - Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation or with c-Kit mutational status unknown.
  - Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or fluorescence in situ hybridization [FISH] demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown.
  - Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).
  - Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).
  - Adjuvant treatment of adult patients following resection of Kit (CD117) positive GIST.
• Imkeldi contains imatinib mesylate, a tyrosine kinase inhibitor that works to slow or prevent the growth of certain cancers by targeting the ABL, KIT or PDGFR protein tyrosine kinases.
• Imatinib was first approved under the brand name Gleevec in a capsule formulation in 2001 (now discontinued), and in a tablet formulation in 2003. Imkeldi is a strawberry flavored oral liquid formulation that offers convenient dosing for patients who have difficulty swallowing tablets, or who require specific dosing tailored to body surface area.
• Imkeldi is administered orally, once or twice a day (depending on the dose), with a meal and a large glass of water.
• Warnings and precautions associated with Imkeldi include edema and severe fluid retention; cytopenias (particularly anemia, neutropenia, and thrombocytopenia); congestive heart failure and left ventricular dysfunction; hepatotoxicity; hemorrhage; gastrointestinal (GI) perforations; cardiogenic shock/left ventricular dysfunction; bullous dermatologic reactions (erythema multiforme and Stevens-Johnson syndrome); hypothyroidism; embryo-fetal toxicity; growth retardation in children and pre-adolescents; tumor lysis syndrome; and renal toxicity.
• Common adverse reactions (≥30%) include edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.

Development timeline for Imkeldi

Further information

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