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FDA Review Article Provides New Insights into Cancer Immunotherapy Product Development; Beneficial to all Involved in Cancer Treatment

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 shrinkage in patients with melanoma when used together rather than by themselves. Also, the combination treatment of GM-CSF (Sargramostim Leukine), with ipilimumab showed patients with metastatic melanoma lived longer than when receiving just ipilimumab alone.

A plan for combination treatment is also part of the FDA review, and recommends that researchers characterize each product individually and provide a strong scientific rationale for the combination. Further, even if the combination regimen uses a standard cytoreductive agent with immunologic effects, dose and timing of administration need to be presented.

“Importantly, the flexible parameters for development and evaluation presented in the document reflect the broader experience now in place and deeper understanding of how immune therapies might be applied in the new generation of trials in development,” said Lisa Butterfield, Associate Professor of Medicine, Surgery and Immunology at the University of Pittsburgh Cancer Institute.

Prior to this review, the definition of product potency, purity, and toxicology evaluation were difficult to define, due to the complexity of cancer immunotherapy products. However, from the series of recommendations made by the FDA in this review, along with the cited FDA guidances, including the state of the art data needed for manufacturing, pre-clinical studies, and clinical trial designs of cancer immunotherapies, the complex landscape of cancer immunotherapy can now be better understood.

The document also addresses the issues of previously only using immunotherapy treatment in advanced and metastatic disease patients. It is now understood that both early and late stage patients can be included in immunotherapy trials, and considerations for both settings are addressed. The potential importance of keeping patients who show signs of early tumor progression on a study from which they may subsequently benefit later is also discussed.

Based on the early new data in the field of cancer immunotherapy, it is a very crucial time for all those involved in the treatment of cancer. This FDA review provides clarity in the development of cancer immunotherapies, which will advance the field forward, and help to make the word “cure,” a reality for patients with cancer.

To read the full review visit,

To read the rest of the inaugural issue visit:

Founded in 1984, the Society for Immunotherapy of Cancer (formerly the International Society for Biological Therapy of Cancer; iSBTc) is a non-profit organization of clinicians, researchers, students, post-doctoral fellows, and allied health professionals dedicated to improving cancer patient outcomes by advancing the development and application of cancer immunotherapy through interaction, innovation and leadership. For more information about SITC, please visit the Society website at

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