currently on the rise with more and more diagnoses being made each year. This disease is more often than not malignant, and causes pain, suffering and early death. The disease affects people that have been exposed to asbestos on a regular basis, and the long latency period means that the symptoms do not become evident until thirty to forty years after the exposure. The treatments used on mesothelioma patients include surgery, radiotherapy, chemotherapy and palliative therapy. However, because the disease takes so long to properly manifest, it is often too late for any of these treatments to be effective by the time mesothelioma has been diagnosed.

However, the FDA (Food and Drug Administration) in the United States have now approved a new drug for the treatment of malignant pleural mesothelioma, which is a variation of the disease which affects the lung cavity and causes symptoms such as breathing difficulties, shortness of breath, persistent coughing, and difficulty swallowing. The approval follows extensive clinical trials of a variety of potential treatments carried out by the National Institute of Cancer as well as by a range of universities and organizations.

The FDA stated in their press release dated 5 th February 2004 that Alimta ‘is the first drug approved for this condition’. FDA Commissioner, Mark B. McClellan also goes on to state: "Up to now there has been no effective treatment for treating mesothelioma. Alimta offers new promise in treating this fatal cancer, and its quick approval demonstrates FDA's commitment to making safe and effective products available as soon as possible."

The approval of Alimta comes after the clinical trials showed that patients treated with a combination of Alimta and Cisplatin lived several months longer than patients that were treated solely with Cisplatin. However, there were some side-effects that were observed in the Alimta patients, which included low white blood count, nausea, fatigue, vomiting, a rash, and diarrhoea. It has been found that administering Alimta along with vitamin B-12 and folic acid supplements can help to reduce the severity of these side effects.

Although the FDA have given approval on this new drug, which is to be distributed by Eli Lilly & Company, there is clearly still a good deal of work to be done. In a letter sent to Eli Lilly by the FDA, Robert Temple, MD with the FDA states: ‘We have not completed validation of the regulatory methods. However, we expect your continued co-operation to resolve any problems that may be identified.’

Alimta is administered intravenously and will be used as a treatment for those patients who cannot have the more common treatments such as surgery. It is a breakthrough that will give new hope to those people who have advanced mesothelioma and therefore no other hope of successful treatment. Nicholas Vogelzang, director of the Nevada Cancer Institute, led the clinical trial on Alimta combined with Cisplatin.

He summed up how difficult it has been to come close to finding a breakthrough drug when he stated: ‘Throughout the 1970s, '80s and really the '90s, we tried a host of different drugs. I was involved in many of these trials and most of them had virtually no effect on the cancer."

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