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Challenges With Including PROs in Oncology Product Labels
The debate over including patient reported outcomes on oncology drug labels continues. The FDA expects well-defined and validated measurement tools and the patient community wants patient experiences to find their way to the label.
Industry, the FDA, and patient groups agree that patient-reported outcomes (PROs) should be included in labeling for oncology products, but there is not consensus on how to do so.
The various stakeholders met in a panel discussion last year at the plenary session of the annual Accelerating Anticancer Agent Development and Validation Workshop in Bethesda, MD, where frustrations were aired and frank views were exchanged.
A report of their discussion was published recently in JAMA Oncology. PRO-based claims are now included in the labeling of as many as 25% of new drug products in the United States, but only 1 of 43 oncology products approved by the FDA between 2006 and 2013 carry such claims.
Read the complete article at Cancer Therapy Advisor: http://bit.ly/1ApmQBf
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Lack of Mutations Associated With Favorable Prognosis in MPN-U
April 25th 2024While the Dynamic International Prognostic Scoring System and bone marrow blasts may predict overall survival, the lack of certain mutations is also associated with a better prognosis for myeloproliferative neoplasm, unclassifiable (MPN-U).
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What We’re Reading: FDA Approves UTI Antibiotic; Ozempic, Wegovy Price Investigation; US Births Fall
April 25th 2024The FDA recently approved an antibiotic for the treatment of urinary tract infections (UTIs) in women; a Senate committee recently launched an investigation into the prices of Novo Nordisk’s diabetes and weight loss drugs; US births fell last year, resuming a national slide after a previous increase during the pandemic.
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