Category: In the News

The unique public-private partnership that undergirded the Lung-MAP trial for almost a decade may serve as a model for future clinical research that is more rapid, innovative, and inclusive, according to a recent report published by Herbst et al in Clinical Cancer Research. Background The Lung-MAP trial was the first National Cancer Institute (NCI)-sponsored precision medicine clinical…

Payers should be asking how they can help answer clinical research questions, along with industry, and other stakeholders, US Food and Drug Administration Commissioner Robert Califf said. During the Friends of Cancer Research Annual Meeting, Califf suggested that private payers, as well as the Centers for Medicare and Medicaid Services, could use their leverage in…

Oncology drug developers should gather patient-reported outcomes (PROs) as part of their efforts to optimize dosing in early development, a Friends of Cancer Research white paper recommends. FOCR released the white paper in conjunction with its annual meeting this month. It was developed by a group of industry, academic, patient and regulatory participants as part of the…

The current class of oncology drug approvals may not be the best example of the US Food and Drug Administration’s evolving approach to dose optimization policy. Agency officials began pushing oncology sponsors more than a year ago to change from looking for the maximum tolerated dose to finding the optimal dose prior to approval. Because…

A key focus for new National Institutes of Health (NIH) Director Monica Bertagnolli is spearheading innovative way to get more patients into in clinical trials to improve evidence generation, she said in recent remarks, including by getting providers more involved in trial enrollment. Her remarks are in line with calls by the non-profit Reagan-Udall Foundation…

What’s New? This week, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year: dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…

What’s New? Yesterday, Friends of Cancer Research (FOCR) hosted its 2023 annual meeting. The agenda featured three substantive sessions on topics FDA has been focused on for the past year including dose selection in early clinical studies, evaluating the use of oncology products in real-life versus in a controlled research setting, and how real-world data can be…

A US Food and Drug Administration advisory committee review of two Acrotech Biopharma LLC accelerated approval drugs with long-overdue confirmatory trial requirements may provide the clearest insight yet into how the Oncology Center of Excellence interprets the “due diligence” requirement for such studies and how sponsors’ planning and implementation strategies may factor into this determination. The Oncologic…

Oncology sponsors soon will better understand the meaning of “ongoing” in the context of a confirmatory trial and the potential barrier it presents to accelerated approval. OCE Director Richard Pazdur said 14 November that guidance on the meaning of “ongoing” is in development – and he also emphasized that without an ongoing confirmatory trial, an…

The Food and Drug Administration’s top cancer drug regulator doesn’t always ask for permission before taking on big initiatives. Richard Pazdur, director of the FDA Oncology Center of Excellence, hates bureaucracy. It stifles his ideas for getting treatments to cancer patients faster — of which there are many. To cut through that bureaucracy, Pazdur has…