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Category: In the News

The Wall Street Journal – FDA Takes Tougher Line on Fast-Tracked Drugs

The Food and Drug Administration is taking a harder line on its program that fast-tracks drug approvals based on preliminary evidence, spurring GSK PLC, Roche Holdings AG and other drugmakers to remake plans for their drugs or pull them from the market. Under the accelerated-approval program, the FDA clears the use of prescription medicines faster than it normally would. The agency…

The Cancer Letter – Ellen Sigal: Pragmatica-Lung may be a model for other trials that are unnecessarily complex

The Pragmatica-Lung trial required many people to start to think differently about conducting phase III clinical trials—and it took a lot of advocacy to make the trial launch quickly, said Ellen Sigal, founder and chair of Friends of Cancer Research. “Given the amount of existing data, it doesn’t have to be a trial that asks…

The Cancer Letter – FDA, NCI align to simplify clinical research, producing a model “pragmatic” registration trial in NSCLC

The phase III trial evaluating the efficacy of ramucirumab plus pembrolizumab in non-small cell lung cancer establishes a new paradigm for clinical trial design. The word “streamlining” is heard with increasing frequency in oncopolitics these days, as NCI, FDA, industry, academia, and advocacy groups push back on clinical trials that, to quote the FDA Cancer…

The Cancer Letter – Roy Herbst: I hope Pragmatica-Lung will become the norm

Pragmatica-Lung is the first of what is likely to be a series of simpler trials with relaxed enrollment criteria and streamlined data collection requirements. The results of such trial would be more generalizable to real-world patient populations. “How do we make these trials simpler? We don’t need a 50-100-page document. We want to try to…

Pink Sheet – Accelerated Approval Is For Patients, Not Sponsors – US FDA’s Pazdur

The US Food & Drug Administration oncology drug review team is getting a lot of attention for cleaning up accelerate approval indications after confirmatory studies fail. But the agency is also drawing some lines in the sand when it comes to granting Accelerated Approval in the first place. In 2021 – in the midst of…

Stat News – Better lab test standards can ensure precision medicine is truly precise

Cancer is becoming less deadly in America. According to the recently released Annual Report to the Nation on the Status of Cancer, overall cancer death rates have continued to decline by about 2% per year over the last several years for Americans of all ages, races, and genders. The decline in cancer death rates is clearly…

InsideHealthPolicy – Friends Of Cancer Research, ACS CAN Urge Congress To Pass VALID

Two leading cancer research advocacy groups are calling on Congress to pass a key diagnostics reform bill, arguing that laboratory-developed tests (LDTs) used to determine treatment for cancer patients are not regulated closely enough and lead to unreliable test results that can impede access to safe and effective treatment. Lisa Lacasse, president of the American…

Pink Sheet – US FDA Says Confirmatory Trials Should Start Before Accelerated Approval But Is Not ‘Dogmatic’

Sponsors should expect increased pressure through the review pathway to ensure products receiving accelerated approval confirm benefits as stakeholders continue working to strengthen the system. Oncology Center of Excellence Director Richard Pazdur wants to squeeze the US Food and Drug Administration’s so-called “period of vulnerability” between clearance and the determination of a clinical benefit. “The…

PR Newswire – Aetion Leads Cross Industry Initiative to Understand Strengths and Limitations of Regulatory Use of Real-World Evidence

NEW YORK, Nov. 29, 2022 /PRNewswire/ — Aetion, the global leader in real-world evidence (RWE) technology and analytics, today announced the launch of the Coalition for the Advancement of RWE through Randomized Controlled Trial Emulation (CARE) Initiative. The first phase of the Initiative will focus on oncology and involves a group of diverse partners including AbbVie, Amgen, AstraZeneca, Bayer, Baylor College of Medicine, Brigham…

InsideHealthPolicy – Pazdur, Califf Seek To Simplify Trials, Ensure They Represent U.S. Patients

FDA chief Robert Califf and Oncology Center of Excellence head Richard Pazdur are worried about clinical trials being moved outside of the United States, and the agency is looking to do something about it, including by simplifying the clinical trial process. The agency has launched Project Pragmatica, which aims to preserves trial randomization but simplify…