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Chronic Myeloid Leukemia

A complete response letter has been issued to Daiichi Sankyo from the FDA, alerting the company to the reasons why the new drug application for quizartinib as a treatment of adult patients with relapsed/refractory <em>FLT3</em>-ITD–positive acute myeloid leukemia would not be approved.

Charles G. Mullighan, MBBS, MSc, MD, discussed with <em>Targeted Oncology </em>the role of genetic variants in understanding a patient’s predisposition to ALL. He highlighted findings in research that may help in utilizing the current understanding of these genetic variants to make treatment decisions for patients with ALL.

The American Cancer Society, Dana-Farber Cancer Institute, Baptist Cancer Center, and the Mayo Clinic report that treatment patterns varied markedly by cancer type and care facility setting for patients with de novo metastatic disease who died within 1 month after diagnosis, based on an analysis of data from 100,848 patients collected from the National Cancer Database, a hospital-based cancer registry that captures 70% of patients in the United States with a new diagnosis.

The FDA recently released 5 new draft guidance documents that promote broader patient eligibility for cancer clinical trials. The policies encourage inclusion of certain individuals who were previously disqualified due to medical conditions or biological factors, including brain metastases, organ dysfunction, prior or concurrent malignancies, chronic infections, and age.

Diffuse large B-cell lymphoma is the most common adult non-Hodgkin lymphoma, accounting for about a third of all cases. The World Health Organization classification recognizes over 15 subtypes of DLBCL, based on the primary tumor site, specific genetic alterations, or association with specific viruses.









































