More Drugs for Cancer in 2012

The applications at the U.S Food and Drug Administration for cancer drugs are rising with 20 submissions expected this year. The increase in the application is due to a better understanding of the molecular makeup of the disease leads to new treatments. Some techniques which are proving successful are the targeting specific gene mutations in tumors and harnessing the body’s own immune system to find and kill cancer cells.

Dr. Richard Pazdur, head of FDA’s office of oncology products said, “There are a large number of drugs being developed in oncology, there is greater understanding of some of the disease processes”. Last year 10 out of the 30 drugs approved by the FDA were for cancer treatment. Dr. Pazdur said that in terms of approval some of the drugs may take next year or longer than expected to review due to issues such as manufacturing and some may not be approved at all. This year some of the cancer drugs approved so far are Roche’s Erivedge for basal cell carcinoma, Pfizer’s Inlyta for kidney cancer, GlaxoSmithKline’s Votrient for soft tissue sarcoma and Leo Pharma’s Picato for actinic keratosis. By Friday the FDA is scheduled to decide on Roche’s application for Pertuzumab which is an antibody designed for use in 25 percent of breast cancer patients whose tumors produce a protein called HER-2 which can fuel cancer growth.

This year the FDA has cleared several cancer drugs ahead of their legislated deadline. Oncology drugs are unique in the sense that the emphasis is on effectiveness rather than safety as the patients are already very ill. However, that does not mean that the FDA will approve every cancer drug that proves through clinical trial demonstrations a statistically significant benefit for patients. This issue is extremely sensitive in drug trials which are designed to show an improvement in “progression free survival”, which is the amount of time a patient lives without the disease getting worse. And trials with PFS as their goal are much shorter than those looking at the rate of overall survival for patients treated with an experimental drug. Last year the FDA revoked the approval of Roche’s Avastin as a treatment for breast cancer patients because though it slowed the progression of the disease there was no evidence that it extended the lives of the patients as well but the drug is still approved for glioblastoma, colorectal, lung and kidney cancers. Dr. Pazdur says that the focus is on the magnitude of improvement demonstrated in clinical trials and also emphasis is on meeting the drug developers more frequently.

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