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New Mesothelioma Treatment :
The asbestos related cancer, mesothelioma, is
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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