US FDA approves Kura-Kyowa’s blood cancer therapy
The U.S. Food and Drug Administration on Thursday approved Kura Oncology (KURA.O), opens new tab and Japanese partner Kyowa Kirin’s (4151.T), opens new tab drug to treat a rare form of blood cancer that has returned or stopped responding to treatment.
The approval offers new hope for patients with a particularly aggressive form of blood cancer who have exhausted other treatment options.
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The once-daily pill, which will be sold under the brand name Komzifti, is approved for acute myeloid leukemia patients with an NPM1 mutation, a genetic change found in about 30% of cases.
Acute myeloid leukemia is an aggressive blood cancer that affects the bone marrow and blood.
The approval was based on a study of 112 patients in which about 21% achieved complete or near-complete remission, with responses lasting a median of five months. Some patients also became independent of blood transfusions during treatment.
The recommended dose is 600 milligrams taken once daily until the disease worsens or side effects become unacceptable, the agency said.
With this approval Komzift competes with Syndax Pharmaceuticals’ (SNDX.O), opens new tab Revuforj, which was approved for the same indication by the FDA last month.
Analysts, on average, expect Komzift to have annual sales of $1.32 billion by 2031, according to LSEG data.
Shares of California-based Kura were up about 3% in afternoon trading.
