FDA Approves Oral Liquid Imatinib for Leukemia and Other Cancer Treatments
The FDA has approved the first oral liquid formulation of imatinib (Imkeldi) for treating certain leukemias and other cancers, including chronic myeloid leukemia (CML), myelodysplastic/myeloproliferative diseases (MDS/MPD), and gastrointestinal tumors.
Developed by Shorla Oncology, the new liquid form aims to improve patient adherence by offering precise dosing and a convenient alternative for those who struggle with tablets.
“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, MBA, Chief Executive Officer of Shorla Oncology.
About Imatinib
Imatinib can be used alone or in combination with chemotherapy, particularly in older patients where it has demonstrated significant effectiveness as a first-line treatment. When paired with chemotherapy, it has been shown to offer better results than chemotherapy alone.
The drug targets the BCR-ABL fusion gene associated with the Philadelphia chromosome, leading to a complete hematologic response in several studies.
“At Shorla, every innovation is driven by our commitment to put patients first. IMKELDI is another step forward as we continue to expand our growing portfolio with products that prioritize accessibility and affordability.” – Rayna Herman, chief commercial officer of Shorla
Imkeldi has no listed contraindications. The most common side effects include edema (often around the eyes or lower limbs), nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, and rash. Edema is typically managed with diuretics, supportive care, or dose adjustments.
Further reading:
Leukemia: Symptoms, Causes, Types, Diagnosis & Treatment
FDA approves Methotrexate for Pediatric acute Lymphoblastic Leukemia
FDA approved a groundbreaking therapy for relapsed or refractory acute leukemia
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