Ricahrd Pazdur, MD, FDA

	2012. A milestone in my professional career marking the 30th anniversary since I finished my medical oncology fellowship and started practicing in the field. Oncology is a much different place today than in the late 1970s when I was an oncology fellow in Chicago, and when I took my first faculty position at Wayne State University in Detroit in 1982. In 1988, I assumed a faculty position at The University of Texas M.D. Anderson Cancer Center, and left Houston in 1999 to join FDA.

	I remember a time when the only drug we had to treat advanced kidney cancer was the hormone, Megace... a time when the only drug to treat metastatic colorectal cancer was 5-fluorouracil... a time when the only drugs to treat chronic myelogenous leukemia (CML) were hydroxyurea and Busulfan... a time when adjuvant therapy in breast cancer was just beginning to be investigated.

	Today is a very different picture. Since 2005 FDA has approved seven drugs for advanced kidney cancer. Oncologists now have multiple options for the treatment of metastatic colon cancer, including the combinations of Camptosar (irinotecan), Xeloda (capecitabine), Eloxatin (oxaliplatin), Avastin (bevacizumab), Erbitux (cetuximab), and Vectibix (panitumumab). Patients with CML have been greatly helped with the introduction of tyrosine kinase inhibitors. Adjuvant therapy, both for breast and colorectal cancers, now has an established role in medical oncology practice, and we have moved the early use of anti-cancer drugs a step further into the neoadjuvant setting in breast cancer.

	There have been many advances during this 30-year period, including the development of curative therapies in childhood malignancies and great strides in supportive care products...

	"Cancer" is a multitude of diseases, and our current classification of cancer based on organ location ("breast cancer," "colon cancer," "lung cancer") will be transformed based on the "molecular fingerprints" of an individual's tumor. The increased understanding of cancer biology will have profound positive implications for all stakeholders with the development of drugs with greater efficacy and less toxicity.

	The future therapeutic advances in oncology will be based on our enhanced understanding of the biology of cancers É One point I discuss [in a recent television appearance] is the need for companies to take a more strategic approach to cancer drug development, and to begin thinking of their business as a "disease" company vs. a "drug" company. Successful drug development will only occur with an in-depth understanding of basic disease mechanisms. This "disease orientation" will require greater collaboration between pharmaceutical sponsors, the academic community, government agencies, and patient groups.

	I have been fortunate to work with a talented team of oncologists, pharmacists, toxicologists, nurses, and safety and public health experts to evaluate cancer drugs. Our staff understands that there are many diverse opinions in the oncology community regarding approval of oncology drugs. The balance between the immediate needs of an individual patient and the assurance of a drug's safety and efficacy for approval will always exist. When appropriate, we have permitted the use of single patient INDs, exemptions to existing protocols, and expanded access programs to allow patient access to promising, yet unapproved, drugs.

	To expedite drug development and our review of applications, FDA has approved oncology drugs on the basis of a single trial and used a variety of clinical trial endpoints -- including overall survival (the time a patient lives before death), progression-free survival (the time a patient lives without their cancer progressing), and response rates (tumor size reduction). FDA has taken advantage of regulatory initiatives for serious and life-threatening diseases, such as fast-track, priority review, and accelerated approval . . .

	Richard Pazdur, MD, is the Director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. These remarks are excerpted from his posting on FDA Voice (https://blogs.fda.gov/fdavoice), Jan. 27.

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Begin thinking of your business as a 'disease' company vs. a 'drug' company