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FDA Extends Review Period for Quizartinib in AML

Jason M. Broderick @jasoncology
Published: Thursday, Apr 04, 2019

The FDA has added 3 months to the review period for a new drug application (NDA) for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia (AML), allowing the agency to review additional data provided by Daiichi Sankyo, the manufacturer of the FLT3 inhibitor.

"We look forward to continued dialogue with the FDA throughout the review process of quizartinib," Arnaud Lesegretain, vice president, Oncology Research and Development and head, AML Franchise, Daiichi Sankyo, said in a press release. "We remain confident in the data supporting our NDA submission and are committed to bringing quizartinib forward as a potential treatment for relapsed or refractory FLT3-ITD AML, a particularly aggressive and difficult-to-treat subtype of AML, where patients need additional targeted treatment options."

The OS benefit with quizartinib in QuANTUM-R was upheld across 3 prespecified sensitivity analyses. In the first, which censored for the effect of transplant, the median OS with quizartinib versus salvage chemotherapy was 5.7 versus 4.6 months (HR, 0.79; 95% CI, 0.59-1.05; P = 0.519). An analysis censoring for the use of other FLT3 inhibitors showed a median OS of 6.6 versus 5.0 months, respectively (HR, 0.74; 95% CI, 0.55-0.99; P = .0203).
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