Over the past decade, the US Food and Drug Administration (FDA) has approved new cancer drugs twice as fast as the European Medicines Agency (EMA), often using accelerated pathways, a new analysis shows. Between 2010 and 2019, the FDA approved almost all oncology therapies ahead of the EMA. Drugs entered the US market about 8…
Introduction Acute myeloid leukemia (AML) is one of the more common blood cancers, characterized by peripheral blood and bone marrow myeloblast proliferation, leading to bone marrow failure and rapid death without treatment. AML primarily affects older adults, with a median age of almost 70 years [1, 2]. Previous research indicates that older patients with AML have substantial…
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. There was a lot going on this week on the COVID-19 vaccines front. We made it through the first of several…
Cancer clinical trials have long had a disparity problem, but a new push for more equitable trials that are both diverse and open to patients with certain health conditions seems to be finally paying off, per new research released at the 2022 annual meeting of the American Society of Clinical Oncology, or ASCO. Fred Hutchinson Cancer…
Name: Brittany Avin McKelvey Age: 29 Birthplace/where you were raised: I was born in Camden, South Carolina, and grew up in Greenville, North Carolina. Where do you live now? Fayetteville Employer: Friends of Cancer Research Job title: I am a science policy analyst at Friends of Cancer Research (Friends). Friends is an advocacy organization based in Washington, D.C., that drives collaboration…
A study conducted under the Lung Cancer Master Protocol (Lung-MAP) found that patients with advanced non-small cell lung cancer whose cancer had progressed on previous immunotherapy lived significantly longer when treated with a combination of ramucirumab (Cyramza®) plus pembrolizumab (Keytruda®) than when treated with one of the current standard therapies for this type of cancer.…
UsAgainstAlzheimer’s wants to replicate the successful multi-stakeholder COVID-19 Evidence Accelerator led by the Reagan-Udall Foundation of the US Food and Drug Administration and Friends of Cancer Research with a similar effort focused on treating Alzheimer’s disease. The patient advocacy group released a request for information on developing an Alzheimer’s Disease Evidence Accelerator on 10 May and hopes…
The theme for this year’s American Society of Clinical Oncology (ASCO) Annual Meeting is “Advancing Equitable Cancer Care Through Innovation,” and in this interview, Randall A. Oyer, MD, medical director, oncology, and medical director, Cancer Risk Evaluation Program, Lancaster General Health, and clinical professor of cancer biology at Penn Medicine, discusses the recent ASCO/Association of…
Drugs granted a breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) were more likely to yield better outcomes for patients with non-small cell lung cancer (NSCLC) compared with drugs that didn’t carry the designation, according to a recent analysis published in Clinical Cancer Research. “Our findings show that the criteria for a…
A Senate proposal to overhaul the way the FDA regulates diagnostics is raising questions over whether the agency has the resources it needs to undertake such a project. The inclusion of the VALID Act (H.R. 4128) in the Senate’s must-pass draft user fee package marks a critical step in realizing changes nearly a decade in the making over how…
