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AACR Provides Scientific Expertise to Assist FDA’s Oncology Center of Excellence in Advancing FDA’s Public Health Initiative “Project Renewal”

Project Renewal will update medical product labeling to allow patients and health care providers to make informed treatment decisions

PHILADELPHIA — The American Association for Cancer Research (AACR), the world’s first and largest cancer research organization, is working with the U.S. Food and Drug Administration (FDA) to advance the FDA’s public health initiative, Project Renewal. Launched in October 2018 by the FDA’s Oncology Center for Excellence (OCE), Project Renewal has an ambitious goal to update labeling information for long-standing off-patent oncology drugs by evaluating accumulated scientific evidence from published research literature. To facilitate this opportunity, the FDA through Project Renewal has engaged Deloitte and the AACR to seek strategic scientific advice and perspective, enhance the scientific integrity of a repeatable process, and gain insights into the evidence evaluation process.

FDA labeling is a central source of scientifically rigorous information on the safe and effective use of anticancer diagnostic and therapeutic products. Over time, labeling can become outdated as new information becomes available in the post-marketing setting. The FDA has a long-standing commitment to supporting generic drug development and competition, which can help reduce prices, improve access, and benefit public health. Project Renewal has been initiated to advance the FDA’s goal to keep generic oncology product labeling up to date on a more frequent basis. In its first year, Project Renewal has developed a set of repeatable processes and procedures to evaluate evidence from published literature to inform regulatory decisions for updated product labeling of older oncology drugs.

“Patients and health care providers rely on accurate medical product labeling to inform care and treatment decisions. It is our goal to keep this information up to date, and we intend to pilot an efficient, scientifically rigorous process to evaluate publicly available safety and efficacy data for long-standing, frequently generic, cancer drugs,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “We are pleased that the American Association for Cancer Research is joining Project Renewal, highlighting our goal to add value to the labeling update process by engaging the oncology community, generating awareness of the importance of FDA product labeling, and creating educational opportunities for clinical and basic cancer scientists as well as oncology fellows to learn how the FDA reviews evidence that informs product labeling.”

Deloitte and the AACR aim to support Project Renewal through creating an objective, repeatable process to engage the oncology research, education, and care community. Project Renewal will leverage the AACR’s scientific expertise and deep network of basic and clinical cancer researchers to provide valuable insights into the evidence evaluation process. Through this collaboration, the AACR sees a long-term benefit to the oncology community by providing cancer scientists, clinicians, and trainees with the unique experience of interacting with the FDA to better understand how the FDA evaluates evidence and to allow the oncology community to inform potential labeling updates.

“The AACR is very proud to work with the FDA on this exciting project that has the potential to help oncologists in their decision making and, most importantly, to guide treatment decisions based on scientific evidence for the benefit of cancer patients,” said Margaret Foti, PhD, MD (hc), chief executive officer of the AACR.

Utilizing the collective wisdom and insights of health care providers devoted to advancing cancer research, this public health initiative hopes to make available the most up-to-date information to patients and oncology professionals through FDA product labeling, while fostering engagement between the FDA and members of the oncology community.