FDA Approves New Imatinib Oral Solution

leukemia © Arif Biswas - stock.adobe.com

The FDA has approved a new Imatinib oral formulation called Imkeldi to treat specific leukemias and other cancers in pediatric patients over the age of one and adults, according to a news release published today. It was developed by Shorla Oncology and approved for 10 indications. Imatinib was first approved as a tablet with the name Gleevec in 2001 and is marketed by Novartis.

“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,” Sharon Cunningham, CEO of Shorla said in the news release.

Imkeldi is a tyrosine kinase inhibitor, which means it can slow or prevent the growth of cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD) and gastrointestinal tumors (GIST).

This year, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD and up to 6,000 with GIST, the press release says.

Specific indications include but are not limited to:

• Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

• Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

• Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

• Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements.

• Patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST).

Dosage is dependent on indication. Doses of 400 mg and 600 mg should be given once a day and an 800 mg dose should be administered as 400 mg twice a day. All doses should be taken with a large glass of water and a full meal.

The most common adverse reactions reported were edema, nausea and vomiting, according to the full prescribing information .

Superficial edema was also seen in 2-6% of CML patients treated with Imatinib. In GIST patients, severe fluid retention was seen in 9 - 13.1%.

Liver function should also be monitored, as well as signs of hematologic toxicity. Complete blood counts should be performed weekly for the first month of treatment and biweekly for the second month.

Grapefruit juice should be avoided during treatment with Imatinib. Breastfeeding women should not take Imatinib.

Imkeldi will arrive in the United States on Jan. 6, 2025 and customer shipments will begin no later than Jan. 13, Rayna Herman, CCO of Shorla said in an email. It will cost $2,350 per bottle.