Leukemia drug recognized by FDA as a breakthrough therapy

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The FDA has granted its breakthrough drug quizartinib a breakthrough treatment. Quizartinib is a FLT3 inhibitor under investigation for the treatment of adult patients with relapsed refractory FLT3-ITD acute myeloid leukemia ( AML ). This identification will accelerate the development of quizartinib and is expected to bring new drugs to patients as soon as possible.

AML is a malignant blood and bone marrow cancer that causes dysfunctional cancerous leukocytes to proliferate and accumulate uncontrollably, and affects the production of normal blood cells. The United States this year is expected to have more than 19000 name of the new diagnosed patients, and more than 10000 Ge AML deaths. The 2005-2011 survey results show that the 5- year survival rate of AML patients is only 26% , which is the lowest among all types of leukemia. FLT3 gene mutation is the most common genetic mutation in AML patients, while FLT3-ITD is the most frequent mutation of FLT3 gene, and about a quarter of AML patients carry this mutation. Compared with patients who did not carry this mutation, patients with FLT3-ITD mutations had a worse prognosis, a higher risk of cancer recurrence, and a greater risk of death after relapse. Even if these patients receive a hematopoietic stem cell transplant ( HSCT ), the chance of cancer recurrence after treatment is still higher than that of patients who do not carry this mutation. Currently, there is no approved treatment for this disease. Therefore, this breakthrough therapy is expected to bring new hope to patients with FLT3-ITD .

In addition to the breakthrough therapy identification, quizartinib also received FDA fast-track qualification for relapsed refractory AML therapy , and the orphan drug qualification for AML issued by FDA and the European Medicines Agency ( EMA ) . Quizartinib is still in the research and development stage and has not been approved in any country. Safety and tolerance have yet to be certified. However, this approval is expected to accelerate the development of the drug, which is really good news for patients.


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