Shorla gains FDA nod for first oral liquid version of Novartis' Gleevec

In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “ammunition in the war against cancer.” Along with a picture of the Gleevec pills, Time exclaimed: “These are the bullets.”

Twenty-three years later, patients no longer need to take a “bullet” to reap the benefits of imatinib as Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of the treatment. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib, Shorla said in a press release.

The therapy can help patients combat myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), gastrointestinal tumors (GIST) and cancers such as chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL).

Shorla, which is based in the U.S. and Ireland, estimated that this year in the U.S. more than 10,000 people will be diagnosed with MDS/MPD, 9,280 will be diagnosed with CML and up to 6,000 will be diagnosed with GIST.

“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation,” Orlaith Ryan, chief technical officer and co-founder of Shorla, said in a statement. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”

Two years ago, Shorla won an FDA nod for Jylamvo, the first oral formulation of Medac Pharma’s injected Rasuvo (methotrexate) for a variety of auto-immune disorders including ALL, rheumatoid arthritis and severe psoriasis. Last month, the FDA expanded the eligible population for Jylamvo to include pediatric patients.  

In 2023, Shorla scored an FDA nod for Nelarabine injection, a treatment for adult and pediatric patients with T‑cell acute lymphoblastic leukemia (T‑ALL) and T‑cell lymphoblastic lymphoma (T‑LBL).