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FDA Review Article Provides New Insights into Cancer Immunotherapy Product Development; Beneficial to all Involved in Cancer Treatment
Date:6/14/2013

Milwaukee, WI (PRWEB) June 14, 2013

A picture of what the FDA is looking for in cancer immunotherapy product development appears in an extensive review article published in the inaugural issue of the Journal for ImmunoTherapy of Cancer. This review outlines a series of recommendations from the FDA, including cited FDA guidances, which should streamline the development of cancer immunotherapy products today and potentially allow for better treatment options for patients with cancer.

Written by members of the FDA’s Office of Cellular, Tissue and Gene Therapies (OCTGT); Center for Biologics Evaluation and Research (CBER); and Center for Drug Evaluation and Research (CDER); this review provides a US regulatory perspective on pre-clinical to first in man studies, and is described by Nora Disis, Professor of Medicine at the University of Washington/Fred Hutchinson Cancer Center, as a “must-read for anyone interested in immunooncology.”

The FDA review is particularly timely as the field of cancer immunotherapy is quickly advancing especially now after promising new data was released from several early phase clinical trials showing significant tumor shrinkage and long term durable response rates in cancer patients treated with various new cancer immunotherapies.

For example, as previously reported here by the Society for Immunotherapy of Cancer (SITC), data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting illustrated new immunotherapies such as Genentech’s, MPDL3280A, and Bristol-Myers Squibb’s nivolumab, both showed significant tumor shrinkage and long term durable response rates in cancer patients involved in separate clinical trials.

More positive data including the use of combination treatments like ipilimumab (Yervoy) with nivolumab also showed significant tumor shri
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