Daratumumab FDA Approved for Transplant-Eligible Patients With Multiple Myeloma

The FDA has now approved daratumumab (Darzalex®, Janssen) to be used in combination with bortezomib, thalidomide, and dexamethasone (VTd) in adult patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant. Daratumumab, a targeted monoclonal antibody, works by attaching itself to a protein called CD38 on multiple myeloma cells. This either directly kills the multiple myeloma cells or allows the body to identify these cells as a foreign invader, therefo...
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Through Project Facilitate, FDA Helps With Expanded Access

As part of a pilot program intended to aid oncology health care professionals in requesting Expanded Access, which makes investigational treatments available to certain patients with cancer, the FDA has announced the creation of Project Facilitate, a call center to aid physicians in the process of submitting Expanded Access requests for individual patients. "Through this pilot program, experienced FDA oncology staff will be available to support physicians and other health care professionals with...
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Cancer Drugs Given Accelerated Approval Lack Survival Benefit

​A recent study reports that only 20% of cancer drugs granted accelerated approval by the FDA ended up showing clinical benefit in terms of overall survival. Because it can take many years to assess a drug's clinical benefit as demonstrated through measures such as overall survival, in 1992 the FDA instituted the Accelerated Approval regulations, which permit drugs that fill an unmet medical need for serious conditions to be approved based on a surrogate end point. A surrogate end point is not i...
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The Impact of the FDA’s Revised Mammography Guidelines: Theresa W. Gillespie, PhD, MA, RN

For the first time in over 20 years, the FDA has proposed amendments to the Mammography Quality Standards Act (MQSA) in an effort to expand the information provided to patients and physicians, modernize standards for mammograms, and enable better enforcement of safety and quality regulations. In this interview with i3 Health, Theresa W. Gillespie, PhD, MA, RN, Professor at Emory University School of Medicine and at Emory's Winship Cancer Institute, discusses the significance of these changes and...
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FDA Proposes Modernization of Mammography Services

​The FDA has proposed regulatory amendments to improve the quality of breast cancer screening by expanding the information provided to patients and physicians, modernizing standards for mammograms, and enabling better enforcement of safety and quality regulations. "Breast cancer is one of the most worrisome health concerns facing women. The FDA plays a unique and meaningful role in the delivery of quality mammography to help patients get accurate screening to identify breast health problems...
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