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…
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…
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…
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…
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…
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…
The US Food and Drug Administration will not require all employees to resume their daily treks to the office going forward, choosing a “hybrid workplace model” that will go into effect in January 2023. Commissioner Robert Califf made the change after the agency completed a six-month pilot exploring workplace flexibilities. The FDA said the new…
SCOOP: FDA SELECTS HYBRID WORK ENVIRONMENT FOR 2023 — Food and Drug Administration leadership has chosen a hybrid work environment for the agency starting in January, a spokesperson confirmed to Katherine on Monday. Each agency center or office will set its own specific policies. Work that must be performed in person — such as laboratory or inspection work —…
Richard Pazdur likely did not surprise anyone when he complained to Friends of Cancer Research Annual Meeting attendees that oncology clinical trials are too complicated. But the director of the US Food and Drug Administration’s Oncology Center of Excellence got a few laughs when he announced his solution. “Well of course we have to launch…
I read with interest the recently published story on the recommendations to streamline data collection in certain NCI trials presented at the Nov. 9, 2022, meeting of the Clinical and Translational Research Committee (The Cancer Letter, Nov. 11, 2022). My reaction: “What took so long?” As a former CTAC member and cooperative group chair I’m…
