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...

Preventing Venous Thromboembolism: Apixaban More Effective With Solid Tumors

A preplanned post-hoc analysis of the AVERT trial, a randomized, placebo-controlled, double-blind clinical trial of apixaban for the prevention of venous thromboembolism (VTE), reveals that among ambulatory patients with cancer initiating chemotherapy, characteristics of both the patient and the cancer in question impact the efficacy of apixaban for VTE prophylaxis. "Patients with active cancer have an increased risk of venous thromboembolism (VTE) complications which is associated with morbidit...

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...

FDA Approves First-Line Pembrolizumab: Metastatic MSI-High/dMMR Colorectal Cancer

Patients with unresectable or metastatic colorectal cancer with high microsatellite instability (MSI) or a deficiency in mismatch repair (dMMR) now have their first frontline immunotherapy option, thanks to the FDA's approval of pembrolizumab (Keytruda®, Merck) in this population. Efficacy and safety were investigated in an open-label phase 3 trial, KEYNOTE-177 (NCT02563002), for which 307 patients with previously untreated MSI-high/dMMR metastatic colorectal cancer and an Eastern Cooperative On...

Treatment Advances in Gastrointestinal Stromal Tumor: Margaret von Mehren, MD

The treatment of gastrointestinal stromal tumor (GIST), a rare tumor type with an estimated incidence of 3,300 to 6,000 new cases per year in the United States, has seen exciting advances this year, first with the FDA's approval of avapritinib for metastatic GIST with platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutations, and more recently with last month's approval of ripretinib for the later-line treatment of metastatic GIST. Margaret von Mehren, MD, principal investigator o...

Subscribe

Get the latest updates delivered to your inbox!

Follow Us

Copyright © 2021 Oncology Data Advisor. All rights reserved.