Avelumab for Urothelial Carcinoma: An Interview With Thomas Powles, MBBS, MRCP, MD

The FDA recently approved avelumab (Bavencio®, EMD Serono, Inc.) for patients with advanced urothelial carcinoma (UC). Thomas Powles, MBBS, MRCP, MD, discusses with i3 Health the implication of this approval and future steps for research and offers community oncologists advice on treating this patient population. What are the most challenging aspects of treating patients with locally advanced or metastatic UC? Thomas Powles, MBBS, MRCP, MD: The overall survival outcomes are poor for the disease....
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The Changing Standards for FDA Oncology Approvals: Talal Hilal, MD

The FDA approval process is in place to ensure that drugs are safe and effective before they are made available to the public. But do the clinical trials that lead to approval truly ascertain whether a drug is efficacious? Fully two-thirds of anticancer drug clinical trials leading to FDA approvals between 2014 and 2019 had at least one important limitation in trial design: lack of randomization, lack of significant overall survival advantage, inappropriate use of crossover, and/or use of a...
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FDA Approves Avelumab for Advanced Urothelial Carcinoma

First-line cisplatin-based chemotherapy prolongs survival in patients with advanced urothelial carcinoma (UC), but disease progression usually occurs within 8 months, and currently no standard second-line therapies are available. Avelumab (Bavencio®, EMD Serono, Inc.), a fully human anti-PD-L1 IgG1 antibody, has shown to have an acceptable safety profile and success in treating this patient population. Based on this evidence, the FDA has now approved avelumab to treat patients with locally advan...
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FDA Approves Pembrolizumab for Cutaneous Squamous Cell Carcinoma

For patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC), pembrolizumab (Keytruda®, Merck & Co., Inc.) is now FDA approved. An immunotherapy originally approved for advanced non-small cell lung cancer, melanoma, high-risk non-muscle invasive bladder cancer, and advanced cervical cancer, among others, pembrolizumab targets the programmed death (PD-1) pathway to prevent cancer cells from hiding. This allows the body's T cells to attack and kill cancer cells. Approval ...
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Gemtuzumab Ozogamicin for Pediatric Acute Myeloid Leukemia: Alan S. Gamis, MD, MPH

In this interview, Alan S. Gamis, MD, MPH, speaks with i3 Health about the recent FDA approval of gemtuzumab ozogamicin (MylotargTM, Wyeth Pharmaceuticals, LLC) for pediatric patients aged 1 month and older with newly diagnosed CD33-positive acute myeloid leukemia (AML). Dr. Gamis, lead investigator of the phase 3 Children's Oncology Group Trial AAML0531, which provided the basis for the approval, discusses the significance of the approval and shares his advice for health care providers as they ...
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