"We applaud this great news," said Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of AACR, the world's oldest and largest scientific organization dedicated to cancer research. "Creating an office to make the review of oncologic products more efficient will accelerate approval of new drugs for treatment and prevention, all of which will benefit the cancer patient."
As envisioned, the new office – to be located in the FDA's Center for Drug Evaluation and Research (CDER) – will streamline the review of applications for oncology drugs and biologics, thereby speeding the development of new therapies.
To support this new office and coordinate work performed throughout the FDA Centers related to the prevention, diagnosis, and treatment of cancer, the FDA is also creating an Oncology Program that will assist cross-agency expert consultation, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for agency interaction and collaboration with the cancer community.
This positive development stems, in part, from the growing relationship between the FDA and the National Cancer Institute under an interagency agreement approved last year to enhance clinical research and the scientific evaluation of new cancer medications and diagnostics.
"The AACR feels confident that this office will increase the clarity, consistency, and predictability of the clinical development pathway so that products could be brought to the patient in the most efficient manner," said Foti.
Founded in 1907, the American Association for Cancer Research is a professional society of more than 22,000 laboratory, translational, and clinical scientists engaged in all areas of cancer research in the United States and in more than 60 other countries. AACR's mission is to accelerate the prevention and cure of cancer through research, education, communication, and advocacy. Its principal activities include the publication of five major peer-reviewed scientific journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers & Prevention. AACR's Annual Meeting attracts more than 15,000 participants who share new and significant discoveries in the cancer field. Specialty meetings, held throughout the year, focus on the latest developments in all areas of cancer research.