The FDA has granted priority review to the new drug application (NDA) of Ziftomenib for patients with NPM1-mutant acute myeloid leukemia (AML). This decision signifies a crucial advancement in providing potential treatment options for individuals facing this aggressive form of AML. Dr. Troy Wilson, president of Kura Oncology, emphasized the significant impact this milestone holds for both patients and the collaborative efforts of the research teams involved, underscoring the promising clinical data supporting Ziftomenib’s efficacy in this specific genetic subset of AML.
Moving forward, the priority review status accelerates the evaluation process of Ziftomenib, signaling a potential expedited pathway to approval. The anticipation of a forthcoming treatment launch highlights the dedication of Kura Oncology and Kyowa Kirin in addressing the unmet medical needs of AML patients. The innovative approach of Ziftomenib offers hope for improved outcomes and quality of life for individuals and their families affected by NPM1-mutant AML, showcasing the commitment to advancing oncology treatments through collaborative research and regulatory engagement.
Read more from targetedonc.com
