The US Food and Drug Administration (FDA) has approved Shorla Oncology’s Imkeldi oral solution to treat certain forms of leukaemia and other cancers in adults and paediatric patients aged as young as one year.
Imkeldi is an advanced liquid formulation of the tyrosine kinase inhibitor imatinib mesylate and has been indicated to help slow or prevent the growth of cancers including chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia (ALL), gastrointestinal tumours (GIST) and myelodysplastic syndrome/myeloproliferative disease (MDS/MPD)
An estimated 9,280 people will be diagnosed with CML, up to 6,000 will be diagnosed with GIST and more than 10,000 will be diagnosed with MDS/MPD in the US this year.
Despite the clinical benefits of imatinib, Shorla outlined that patient adherence can be a problem, highlighting the need for a more accessible, patient-friendly oral solution delivery system.
Shorla’s Imkeldi has a strawberry flavour and does not require refrigeration, which the company hopes will improve adherence and accessibility to the drug.
Commenting on the FDA’s decision, Shorla’s chief executive officer, Sharon Cunningham, said: “We are thrilled to offer an oral solution option for patients with leukaemia and other cancers, a meaningful advancement for thousands in need.
“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.”
The approval comes just one month after the FDA approved Shorla’s Jylamvo to treat paediatric patients with ALL and polyarticular juvenile idiopathic arthritis, making the drug the only oral liquid methotrexate on the market approved for both adult and paediatric populations.
Cunningham said at the time of the October announcement: “This approval follows Jylamvo’s successful use in adult patients and represents a critical step forward in addressing the unmet needs of paediatric care in oncology and autoimmune diseases.”
The US regulator also approved Shorla’s Tepylute, a ready-to-dilute liquid formulation of thiotepa, in July to treat breast and ovarian cancer. The formulation removes the need for complex and time-consuming reconstitution and allows for ‘just in time’ preparation.