FDA grants priority review to quizartinib for certain adults with acute myeloid leukemia
Click Here to Manage Email Alerts
The FDA granted priority review to quizartinib for treatment of certain patients with acute myeloid leukemia.
The designation applies to use of the agent in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy after consolidation, by adults with newly diagnosed FLT3-ITD-positive AML.
Approximately 25% of AML cases have FLT3-ITD mutations. These mutations are associated with unfavorable prognosis — including higher risk for relapse and shorter OS — than FLT3-ITD wild-type disease.
Quizartinib (Daiichi Sankyo) is a selective FLT3 inhibitor.
A new drug application is based on results of the randomized phase 3 QuANTUM-First trial, which included 539 adults (median age, 56 years) with newly diagnosed FLT3-ITD-positive AML.
Researchers randomly assigned patients 1:1 to quizartinib (n = 268) or placebo (n = 271) in combination with standard anthracycline- and cytarabine-based induction and consolidation regimens.
Eligible patients — including those who underwent allogeneic hematopoietic stem cell transplantation — received single-agent quizartinib or placebo for up to 36 cycles.
OS served as the primary endpoint. Secondary endpoints included EFS, post-induction rates of complete remission and composite complete remission, and the percentage of patients who achieved complete remission or composite complete remission with FLT3-ITD minimal residual disease negativity.
Median follow-up was 39.2 months.
Previously released results showed improved OS in the quizartinib group (median, 31.9 months vs. 15.1 months; HR = 0.77; 95% CI, 0.61-0.97).
“There is a need for new targeted therapy options for patients with acute myeloid leukemia, and the results of the QuANTUM-First trial showed that quizartinib in combination with standard chemotherapy has potential to change the current standard of care for newly diagnosed patients with the historically difficult-to-treat FLT3-ITD subtype," Ken Takeshita, MD, global head of research and development at Daiichi Sankyo, said in a company-issued press release. "The FDA’s prioritization of this application reflects the importance of the data, and we will continue to work with the FDA and other global regulatory authorities to support the review of quizartinib for the treatment of patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia."
Read more about
Click Here to Manage Email Alerts