Navigation Links
FDA Review in Journal for ImmunoTherapy of Cancer Offers New Insights into Cancer Immunotherapy Product Development & Clinical Evaluation

Milwaukee, WI (PRWEB) May 30, 2013

A picture of what the FDA is looking for in cancer immunotherapy product development appears in an extensive new review article published in the inaugural issue of the Journal for ImmunoTherapy of Cancer. Providing a US regulatory perspective on pre-clinical to first in man studies, the review 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 review was 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).

As mechanisms of tumor immune escape have become better defined, approaches that combine two or more modalities to overcome immune resistance are increasingly being proposed and the FDA provides a plan for such approaches. The FDA 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.

The complexity of cancer immunotherapy products has made issues such as the definition of product potency, purity, and toxicology evaluation difficult. This review and series of recommendations from the FDA, in addition to the cited FDA guidances, provides considerations for product development that will be valuable for cell based and vaccine therapies, along with state of the art data needed for manufacturing, pre-clinical studies, and clinical trial designs of cancer immunotherapies. The review is particularly timely, given the rapid series of important recent advances and refinements of therapeutic approaches, and the significantly positive clinical outcomes achieved.

The document also addresses the issues of only testing immunotherapeutic interventions in advanced and metastatic disease patients, as well as of early tumor progression while in a study. 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. These are both important steps forward, based on the lessons learned in the field. In short, the recommendations provided by the FDA should streamline the development of complex biologics in immunooncology today.

To read the full review visi,

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

# # #

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. FDA/PhUSE Collaboration: Study Data Reviewer’s Guide Work Package v1.1 Available
2. Wysebridge Patent Bar Review Supports the National Foundation for Celiac Awareness (NFCA) During Celiac Awareness Month
3. BioDelivery Sciences Provides Business Review and Update in Conjunction with Filing of First Quarter 2013 Financials
4. Wysebridge Patent Bar Review Launches America Invents Act (AIA) Study Suite
5. Infinata’s BioPharm Insight to Offer Exclusive Preview of 2013 Key Reports at the BIO International Conference and Partnerships in Clinical Trials
6. “Scientific And Medical Research On The Successful Treatment Of Type 1 + 2 Diabetes With Alkaline Reduced Water” is Reviewed in Today’s Bawell Water Ionizer Health Report
7. Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by the FDA and EMA for the Visual Detection of beta-amyloid in Alzheimers Disease
8. NW Bio To Review Its Leadership Position In Immune Therapy At The 25th Annual Roth Conference
9. Unigene Comments on FDA Advisory Committee Review of Salmon Calcitonin
10. Computer Review Announces New Tools to Deal with the Flood of Information from the Biotechnology Sector
11. New Science Fiction Novel Paints Terrifying Picture of Dystopian Future: Young Author Receives Glowing Reviews
Post Your Comments:
(Date:6/23/2016)... , ... June 23, 2016 , ... ... YM (Yeast and Mold) microbial test has received AOAC Research Institute approval 061601. ... microbial tests introduced last year,” stated Bob Salter, Vice President of Regulatory and ...
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the ... at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field Application ... team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding our ...
(Date:6/23/2016)... On Wednesday, June 22, 2016, the ... the Dow Jones Industrial Average edged 0.27% lower to finish ... 0.17%. has initiated coverage on the following equities: Infinity ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ... ). Learn more about these stocks by accessing their free ...
(Date:6/23/2016)... June 23, 2016 ... report to its pharmaceuticals section with historic and ... and much more. Complete report on ... pages, profiling 15 companies and supported with 261 ... . The Global Cell ...
Breaking Biology Technology:
(Date:6/2/2016)... 2, 2016   The Weather Company , an IBM ... an industry-first capability in which consumers will be able to ... ask questions via voice or text and receive relevant information ... Marketers have long sought an advertising solution that ... be personal, relevant and valuable; and can scale across millions ...
(Date:5/16/2016)... --  EyeLock LLC , a market leader of iris-based ... IoT Center of Excellence in Austin, Texas ... embedded iris biometric applications. EyeLock,s iris authentication ... with unmatched biometric accuracy, making it the most proven ... platform uses video technology to deliver a fast and ...
(Date:4/28/2016)... , April 28, 2016 First quarter ... (139.9), up 966% compared with the first quarter of 2015 ... totaled SEK 589.1 M (loss: 18.8) and the operating margin was ... (loss: 0.32) Cash flow from operations was SEK 249.9 ... 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. The ...
Breaking Biology News(10 mins):