The U.S. Food and Drug Administration approved a liquid form of imatinib to treat some forms of aggressive systemic mastocytosis (SM) and several cancer types, Shorla Oncology announced recently. Shorla markets imatinib under the brand name Imkeldi.
The oral flavored liquid solution will contain 80 milligrams of imatinib per milliliter and does not require refrigeration, the company said. The manufacturer said it expected the liquid to improve dosing accuracy and enhance treatment adherence.
What are the types of SM?
There are five subtypes of SM: indolent SM, the most common and least severe subtype; smoldering SM, which can progress to more serious illness; aggressive SM; SM with an associated hematologic neoplasm; and mast cell leukemia, the rarest and most severe subtype.
“We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” Shorla CEO Sharon Cunningham said in a statement. “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.”
Imatinib is a tyrosine kinase inhibitor that was initially approved for the treatment of chronic myeloid leukemia (CML) in 2001. In the context of SM, imatinib is relevant for the minority of patients with aggressive SM without the KIT D816V mutation or having unknown KIT mutational status.
Several studies demonstrated that patients with KIT D816V negative aggressive SM improved significantly under imatinib treatment, experiencing a decrease in serum tryptase levels, mast cell concentration in the bone marrow and meaningful symptom relief.
The drug is also valuable in other conditions such as CML, acute lymphoblastic leukemia (ALL), hypereosinophilic syndrome, chronic eosinophilic leukemia (CES) and malignant gastrointestinal stromal tumors (GIST).
Common adverse effects of imatinib are mild and include nausea, vomiting, muscle cramps, fatigue, diarrhea and abdominal pain. More severe adverse effects observed in a minority of patients include cardiac dysfunction, liver damage, anemia, immunosuppression and gastrointestinal hemorrhage.
The new form of imatinib should be administered with the help of a syringe or a press-in bottle adapter to ensure optimal dosing. Experts recommended taking it together with food and water.
