WASHINGTON — President Biden plans to nominate Dr. Monica M. Bertagnolli, an oncologist who has run the National Cancer Institute for the past six months — and a cancer patient herself — to be the next director of the National Institutes of Health, an administration official said. If confirmed by the Senate, Dr. Bertagnolli would be…
The FTC ruled on April 3 that Illumina must divest itself of the cancer diagnostics firm Grail, a decision designed to promote competition in the multi-cancer early detection market by providing equal access to essential DNA sequencing technology. U.S. antitrust regulators joined their European counterparts this month by ruling that DNA sequencing giant Illumina must…
A clinical trial that breaks new ground with its dramatically streamlined design and unusually broad eligibility criteria is now opening and available to patients with stage 4 or recurrent non-small cell lung cancer at cancer treatment clinics all across the United States. The S2302 Pragmatica-Lung trial, developed and led by the SWOG Cancer Research Network,…
Jane Perlmutter, PhD, MBA, has been honored with the Patient Advocate Award for her decades-long dedication to peer support for newly diagnosed patients and advancing cancer research advocacy. Dr. Perlmuttter’s commitment to supporting patients with cancer and expanding the role of patient advocates in clinical trials came as a direct result of her own diagnosis…
A novel endpoint for a cancer drug’s accelerated approval is more likely to get the go ahead from the US Food and Drug Administration if the sponsor has a fully accrued post-marketing study underway at the time of application, Oncology Center of Excellence Deputy Director Paul Kluetz said. Kluetz noted this is one way in…
Comments submitted in response to the FDA Oncology Center of Excellence’s (OCE) recent dose optimization guidance demonstrate stark differences in stakeholder perspectives, ranging between solid support and fervent opposition to the operational approaches proposed by FDA’s guidance. In this extensive analysis, AgencyIQ unpacks the contrasting opinions regarding what dose optimization truly means and what is…
The US Food and Drug Administration released a draft guidance this week outlining recommendations for companies designing trials intended to support accelerated approval for oncology drugs. The draft guidance provides nonbinding recommendations for the design of randomized controlled trials and single-arm trials for accelerated approval, along with recommendations for confirmatory trials post-approval. The public can comment on the guidance…
In releasing a draft guidance earlier this year on dose optimization for cancer therapies, the US Food and Drug Administration is steadily advancing its decades-long campaign to move the industry away from the default use of a maximum-tolerated dosing paradigm in clinical trials and toward a more patient-centered approach. On the front lines of that campaign are…
Cancer drugmakers pursuing FDA’s accelerated approval mechanism to sell their treatments more quickly should opt for randomized controlled trials instead of giving the experimental therapy to everyone. The Food and Drug Administration announced Friday draft guidance on clinical trial considerations to support accelerated approval of oncology therapeutics. Accelerated approval has come to the forefront after the controversy behind the approval…
FDA’s dose-optimization requirements for cancer therapies are sure to shake up clinical trial designs and clinical development strategies, and companies are calling for more clarity on how exactly the processes will change. In public comments submitted in response to FDA’s draft guidance on dose optimization for oncology therapies, which was released in January, representatives from biotech companies…
