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THE PHARMA REVIEW (APRIL - MAY, 2008)

Study of Survival Data of Oncology Products Granted Accelerated Approval Status By USFDA - A Meta Analysis

Rajneesh Vats, Nilanjan Saha, Manthan Janodia, D. Sreedhar, Virendra S. Ligade, N. Udupa

Abstract: The global burden of cancer continues to increase. In the year 2000, 5.3 million men and 4.7 million women developed a malignant tumor and 6.2 million died from the disease. Apart from this, 22.4 million persons were living with the disease in the year 2000. Such a huge prevalence demands a greater number of anticancer drugs to be manufactured and approved by USFDA so that these may reach the patients in time. Accelerated approval is a component of the Code of Federal Regulations that gives the FDA authority to grant marketing approval for a new drug product on the basis of adequate and well-controlled studies establishing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit.

Introduction

The global burden of cancer continues to increase year-by-year given the current trend of smoking prevalence and the adoption of modern lifestyles. The predictions are that the number of new cases is expected to grow by 50% over the next 20 years to reach 15 million by 2020. Worldwide 12% people die from cancer and in industrialized countries more than 1 in 4 will die from the disease. This represents an increase of around 19% in incidence and 18% in mortality since 1990 (Fig. 1).

In terms of incidence, the most common cancers worldwide (excluding non-melanoma skin cancers) are lung (12.3% of all cancers), breast (10.4%), and colorectal (9.4%). In terms of mortality also, lung cancer accounts for most number of deaths i.e. 1.1 million annually (17.8% of all cancer deaths). The other two among the first three are stomach cancer (10.4%) and liver cancer (8.8%) (Fig. 2 and 3).

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