The Food and Drug Administration (FDA) granted a priority review to quizartinib for the treatment of patients with relapsed or refractory FLT3-ITD acute myeloid leukemia (AML).
The Food and Drug Administration (FDA) granted a priority review to quizartinib for the treatment of patients with relapsed or refractory FLT3-ITD acute myeloid leukemia (AML), according to Daiichi Sankyo Company, the manufacturer of the FLT3 inhibitor.
The new drug application included results from the phase 3 QuANTUM-R study, which was the first randomized study that proved that a FLT3 inhibitor can prolong overall survival when given alone as an oral agent in patients with relapsed or refractory FLT3-ITD AML. The trial included 367 patients who were randomized 2:1 to receive either quizartinib or salvage chemotherapy.
The primary endpoint of the study — which was met – was to see if quizartinib improved overall survival compared to chemo.
Common grade 3 or higher side effects were infection and febrile neutropenia. Common laboratory side effects included decreased white blood cell count, decreased lymphocyte count, decreased hemoglobin, decreased neutrophil count and decreased platelet count.
New analyses of the study will be presented at the 60th Annual Meeting of the American Society of Hematology, held in San Diego, on Monday, Dec. 3.
"If approved, quizartinib has the potential to meaningfully advance treatment for patients with relapsed or refractory FLT3-ITD AML. Patients need more treatment options for this type of AML, which is particularly aggressive and difficult to treat. We are pleased that the FDA has filed our application for quizartinib for patients with relapsed or refractory FLT3-ITD AML, and granted priority review," Arnaud Lesegretain, vice president of oncology research and development and head of the AML franchise at Daiichi Sankyo, said in a statement.
Priority reviews are given to drugs that show promise in treating serious diseases and conditions, and expedite the time it would take for the FDA to review — and potentially approve – the agent. The FDA plans to make its decision on quizartinib by May 25, 2019.
"Coupled with the recent acceptances of marketing applications for quizartinib in Japan and (Europe), we look forward to working with regulatory authorities in the U.S., Japan and (Europe) to bring quizartinib to patients."