fda-approvals-june-2019

FDA Approves Three Agents for Cancer Indications

First Ever Treatment for Tenosynovial Giant Cell Tumor. The United States Food and Drug Administration (FDA) granted approval to pexidartinib (Turalio™, Daiichi-Sankyo) for treatment of patients with symptomatic tenosynovial giant cell tumor (TGCT) with severe morbidity or functional limitations who cannot be treated with surgery. The approval was based on the phase III ENLIVEN study, […]

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Breast Cancer Risk Increased by Menopausal Hormonal Therapy

Menopausal hormonal therapy (MHT), used to alleviate the symptoms of menopause, has been associated with an increased risk of breast cancer; but findings from previous studies have been inconsistent and lack long-term follow-up. A large, new meta-analysis of published and unpublished sources evaluated 108,647 postmenopausal women, who developed breast cancer, for history of MHT use […]

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Full Chemotherapy Dose Improves Survival in Early Breast Cancer

For patients with early-stage breast cancer, surgery followed by adjuvant chemotherapy is a standard of care. However, because of the toxicities associated with chemotherapy, many patients receive reduced or modified doses. A new study sought to evaluate the impact of full versus modified-dose adjuvant chemotherapy on breast cancer survival. The investigators analyzed data from 1,302 […]

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Impact of Exercise and Weight Loss on Breast Cancer Lymphedema Outcomes

Lymphedema is a common complication of curative breast cancer treatment, occurring in as many as 50% of patients undergoing axillary lymph node dissection. Because lymphedema occurs more commonly in patients with excess body weight, current guidelines recommend weight loss and home-based exercise as a strategy to manage breast cancer-related lymphedema. However, this recommendation has not […]

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New Guidelines on Management of Venous Thromboembolism

Cancer patients are significantly more likely to develop venous thromboembolism (VTE) than people without cancer. Appropriate risk assessment, prophylaxis, and management of VTEs is essential to prevent the long-term complications and risk of death from deep vein thrombosis and pulmonary embolism. In a new Clinical Practice Guideline released by the American Society for Clinical Oncology […]

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Antidepressants Linked to Reduced Cancer Mortality

Patients with cancer often experience depression and anxiety, and these comorbid conditions are independent risk factors for premature mortality. Many patients with cancer take antidepressants to manage these conditions, but little is known about the link between antidepressant use and mortality in patients with cancer. To evaluate this, a large, nationwide, 4-year historical cohort study […]

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Nivolumab Associated With Long-Term Survival in Multiple Tumors

Immunotherapy targeting the PD-1/PD-L1 axis has become a standard component of care across multiple tumor types, including non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), and others. While these agents result in durable responses, there is limited data regarding long-term survival in these patients. In a secondary analysis of the phase I CA209-003 […]

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