Notizie AIOM – anno XVII
FDA Extends Review Period for Quizartinib in AML
April 4, 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 ...Leggi tutto
ALK Resistance Mutations and Efficacy of Lorlatinib in Advanced Anaplastic Lymphoma Kinase-Positive Non–Small-Cell Lung Cancer
Lorlatinib is a potent, brain-penetrant, third-generation anaplastic lymphoma kinase (ALK)/ROS1 tyrosine kinase inhibitor (TKI) with robust clinical activity in advanced ALK-positive non–small-cell lung cancer, including in patients who have failed prior ALK TKIs. ...Leggi tutto
Preventive drugs in the last year of life of older adults with cancer: Is there room for deprescribing?
The continuation of preventive drugs among older patients with advanced cancer has come under scrutiny because these drugs are unlikely to achieve their clinical benefit during the patients’ remaining lifespan. A nationwide cohort study of older adults (those aged ...Leggi tutto
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance treatment strategies for helping youth addicted to nicotine as a result of the epidemic rise in teen use of e-cigarettes
April 1, 2019 - As we continue to address the troubling epidemic of youth e-cigarette use, we’ve committed to employing a number of tools as part of our Youth Tobacco Prevention Plan to ensure no tobacco products are being marketed to, sold to, or used by kids. We’ve ...Leggi tutto
FDA warns homeopathic firms for putting patients at risk with significant violations of manufacturing quality standards
April 1, 2019 - The U.S. Food and Drug Administration today posted warning letters to four companies who produce homeopathic drug products for significant violations of current good manufacturing practice (CGMP) regulations, including a letter to King Bio Inc. of Asheville, ...Leggi tutto