Usfda Seeking Approval Of Dc Vax Essay

1303 words - 6 pages

Early detection of breast cancer has helped prevent many fatalities, but what if we had a vaccination for all types of cancer? There is great hope for a cancer vaccination in the works as we speak. The PEI (Paul-Ehrlich-Institut,) which is the FDA of Germany, has found a way to get an accelerated approval to get a cancer vaccine called DCVax possibly approved by the USFDA (United States Food and Drug Administration). Over the past two and half years, a company by the name of Northwest Biotherapeutics has made major progress in finding a vaccination for all types of cancer through recent clinical trials. The trials have shown tremendous results with increased life expectancy and substantial results in the shrinkage of tumors.
Cancer has been around for over a 100 years and we still have yet to find a cure, or some sort of vaccination. Cancer is best described as an uncontrolled growth of malignant (cancer) cells attack the lymph nodes and your body’s immune system. Some types of cancer may cause alterations that affect regular cell growth and division. When these alterations, or mutations occur, they develop a mass of tissue called a tumor (Breast Cancer Treatment). With this vaccine, DCVax, participants that were included in these clinical trials have shown amazing results in overall survival time and shrinkage of tumors.
The desire of finding a vaccination for cancer is remarkably high in today’s society. For some reason, FDA is hesitant about authorizing the DCVax. A corporation by the name of Dendreon discovered the first ever FDA approved vaccine called Provenge. It was given to individuals for the treatment of particular forms of prostate cancer. The patients that receive this vaccine has decreased the chance of death by 22.5% (PROVENGE® (sipuleucel-T) Is FDA Approved.) The FDA most recently announced the approval of a drug called Zykadia, which is for late stage lung cancer. The clinical trial involving 163 individuals that received the Zykadia, about half of their tumors showed signs of shrinkage and effects lasted about seven months (FDA approves Zykadia.) Both Zykadia and Provenge have more side effects than the DCVax, not to mention the information on clinical trials resulting in much higher overall outcome of the patient’s survival, less side effects, and more cost effective.
There are multiple reasons why the DCVax should be approved by the FDA, because in just a short period of time of about 2.5 years, Northwest Biotherapeutics has found a way to get an accelerated approval from the PEI (Paul-Ehrlich-Institut), which is the FDA of Germany. On March 10, 2014, DCVax was the first to receive a “Hospital Exemption” advanced program under Section 4b of the German Drug Law. Recently diagnosed and reoccurring cancer patients could now receive the vaccine outside the Company’s clinical trial and bill whole cost. The vaccine was the first “somatic” cell therapy product; a somatic cell is classified as all cells in the body besides...

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