Biologics Regulation and ResearchThe People and Work of Buildings 29 & 29A

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CBER licensed Herceptin (trastuzumab) in September 1998, a monoclonal antibody that represented a new approach to treatment of metastatic breast cancer. Bioengineered from an altered antibody in a mouse, the monoclonal antibody bound to HER2, a protein that regulates cell growth that is found on certain normal cells. This ability to bind to the protein enabled the antibody to interfere with tumor cell growth. In metastatic breast cancer, about 30 percent of the tumors express excess HER2, so this would be useful only in patients with tumors of that character. FDA approved Herceptin alone for those who received little benefit from chemotherapy or as a first-line treatment when used in combination with paclitaxel.

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CBER and the National Cancer Institute (NCI) began a collaborative research and clinical project in 2001, the Clinical Proteomics Program, to make a comprehensive study of all proteins in living cells and apply this to the clinical care of cancer patients. Drs. Emanuel Petricoin in CBER and Lance Liotta of NCI led the effort, which was funded for three years about $1 million annually. The two groups had already developed new or improved analytical technology for the purpose, have identified more than 130 different proteins found in several types of cancer. Using the latest microscopic procedures to biopsy cells pre- and post-treatment would allow the team to analyze the impact of different therapies on tumor protein patterns. Among other benefits the Program hoped to achieve was earlier ability to diagnose cancer, a better sense of toxic and beneficial effects from the lab before clinical application, and improved understanding of tumors at the protein level, and better treatments for cancer patients.  The following year the Proteomics collaborative reported preliminary results in The Lancet on diagnostic developments they uncovered by using protein patterns found in normal serum and that collected from an ovarian cancer patient.

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Dive preface class grid-col-6 Image Modified Dive preface class grid-col-6 Image Modified Span class caption Dr. Lance A. Liotta, at right, and Dr. Emanuel F. Petricoin, at left. Span class credit FDA History Office

The 2007 Food and Drug Administration Amendments Act gave the agency authority to require a manufacturer to submit and carry out a Risk Evaluation Mitigation Strategy (REMS) for selected biologics or drugs to ensure a product’s benefits outweigh its risks as a condition of the product’s approval. FDA issued its first guidance under this authority in 2009. The elements of a REMS included a variety of communication devices to help inform the patient about using the therapy, such as medication guides and patient package inserts; a communication plan for the healthcare provider; and other elements to ensure safe use of the product aimed at the prescriber, dispenser, and the patient. The draft guidance addressed the format and content of the REMS, its assessment, and a timetable for submitting it.

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