FDA approves Imkeldi oral solution for leukemia and cancer treatment

Shorla Oncology announced FDA approval of Imkeldi, the first oral liquid formulation of imatinib, for the treatment of certain forms of leukemia and other cancers. 

Shorla's Imkeldi is the oral liquid formulation of imatinib, a drug initially developed and marketed by Novartis as Gleevec. Approved in 2001, Gleevec was a breakthrough targeted therapy for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST), transforming treatment by specifically inhibiting cancer cell growth.

The solution is designed to address needs such as difficulty swallowing pills or precise dosing tailored to body surface area. 

In the U.S., an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD, and up to 6,000 with GIST in 2024.

This marks Shorla’s fourth FDA approval.