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....

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...

Successfully Treating Kaposi Sarcoma: Robert Yarchoan, MD

Robert Yarchoan, MD, Chief of the HIV and AIDS Malignancy Branch at the National Cancer Institute (NCI), recently spoke with i3 Health about the approval of pomalidomide (Pomalyst®, Celgene) for Kaposi sarcoma in patients with and without HIV. In this second installment of his interview, Dr. Yarchoan shares valuable advice with oncologists as they seek to enhance outcomes and treatment experiences for patients with Kaposi sarcoma. What advice can you share with oncologists treating patients with...

Burosumab-twza for Tumor-Induced Osteomalacia: Suzanne Jan de Beur, MD

In this interview with i3 Health, Suzanne Jan de Beur, MD, discusses the recent approval of burosumab-twza (Crysvita®, Ultragenyx Pharmaceutical, Inc.), for patients with tumor-induced osteomalacia (TIO) whose tumors are unable to be localized or resected. Dr. Jan de Beur, lead investigator of one of the phase 2 clinical trials on which the approval was based, explains the challenges involved in diagnosing and treating TIO and discusses the significance of the approval of burosumab-twza for pati...

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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