Two U.S. government agencies, two pharmaceutical companies and an academic cooperative trials group are collaborating to conduct a pragmatic clinical trial of a combination therapy for advanced non-small cell lung cancer. They hope the trial, which FDA has dubbed Project Pragmatica, will be a model for quickly answering urgent questions that can shape clinical practice.…
YORBA LINDA, Calif., Nov. 18, 2022 /PRNewswire/ — Inspired by the success of the first Nixon National Cancer Conference in 2021, the Richard Nixon Foundation has announced the second annual conference will be held at the Richard Nixon Presidential Library and Museum on December 7 and 8, 2022. Top clinicians, researchers, journalists, NCI-designated cancer center directors, patients, patient advocates,…
Oncology sponsors could overcome problems enrolling US patients in clinical trials by enlisting the National Cancer Institute and its network, a US Food and Drug Administration official said. Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said the NCI could be put in charge of US clinical trial enrollment and leave sponsors to…
Pazdur prepared to unveil one pilot program, and previews another: At a meeting held today by the Friends of Cancer Research (FOCR) organization, several key FDA oncology regulators from its Oncology Center of Excellence offered observations on an extensive list of regulatory topics, including new pilot programs, the accelerated approval program, the FDA’s acceptance of…
Targeted cancer drugs typically require specific tests to identify patients who could benefit the most from the therapies. But as FDA oncology chief Richard Pazdur, M.D., sees it, these companion diagnostics don’t serve patients that well. Existing cancer companion diagnostics are bundled with the specific cancer drugs they’re approved for. But the FDA is looking…
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. This week, we heard from FDA Commissioner Robert Califf and Oncology Center of Excellence (OCE) Director Richard Pazdur about FDA’s return…
The National Cancer Institute could handle US enrollment of studies testing cancer drugs under a proposal floated by FDA’s cancer chief as part of a larger effort to improve clinical trials. Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, proposed the idea Thursday as a potential solution to ensure…
Drug companies need to “step up and take their drugs off the market as rapidly as possible” if a follow-up study shows their fast-tracked product doesn’t work, FDA’s oncology chief said. Richard Pazdur, director of the Food and Drug Administration’s Oncology Center of Excellence, made his remarks in addressing criticisms of the accelerated approval…
The FDA’s oncology department, under the leadership of Richard Pazdur, M.D., is getting tougher on accelerated approvals for cancer drugs. When considering accelerated approvals for oncology therapies, the department wants to have a company’s confirmatory trial plan upfront, not after the therapy is already on the market, Pazdur said Thursday. “The major thing that we’re…
FDA Commissioner Rob Califf sat down for a conversation on Thursday morning with Rick Pazdur, head of the FDA’s Oncology Center of Excellence, with the two agreeing that accelerated approval reforms need to happen, that multi-regional clinical trials are always better than single-country trials, and that returning every last FDAer to the White Oak campus…
