In July 2002, The U.S. Food and Drug Administration and Eli Lilly Company announced that Alimta (pemetrexed) would be made available to patients with malignant pleural mesothelioma. The drug, a chemotherapy treatment is not fully FDA approved but will be made available to "qualified patients who have been diagnosed with malignant pleural mesothelioma and have not yet received treatment." The FDA allows Alimta to be used under a so-called "Expanded access program," that allows new treatments available to patients with diseases like mesothelioma, for which there is no other treatment or satisfactory alternative therapy. Under this program, patients with mesothelioma will be given access to Alimta while the FDA review process is going forward and the treatment is pending review.
The FDA agreed to allow patients use of Alimta under the "expanded access program" based on the initial results from clinical trials. The results of a Phase III trial discussed at the annual meeting of the American Society of Clinical Oncology, showed that patients treated with Alimta and cisplatin had better survival rates, had less pain and shortness of breath. Pemetrexed (Alimta) is a new antifolate, a type of drug that targets the folic acid metabolic pathway, inhibiting the availability of certain B complex vitamins. The downside, in the trial was that in some patients there was decrease in the number of white blood cells used to fight infections.
The FDA agreed to allow patients use of Alimta under the "expanded access program" based on the initial results from clinical trials. The results of a Phase III trial discussed at the annual meeting of the American Society of Clinical Oncology, showed that patients treated with Alimta and cisplatin had better survival rates, had less pain and shortness of breath. Pemetrexed (Alimta) is a new antifolate, a type of drug that targets the folic acid metabolic pathway, inhibiting the availability of certain B complex vitamins. The downside, in the trial was that in some patients there was decrease in the number of white blood cells used to fight infections.
The clinical trial was the largest ever conducted in the US for a mesothelioma treatment.
The findings: Tumors shrank in 41 percent of patients on Alimta (pemetrexed) in combination cisplatin, a more common chemotherapy treatment. Cisplatin resulted reduced to tumors in 17 percent of patients receiving it. Patients on the Alimta (pemetrexed) cisplatin combination lived nearly three months longer than those on cisplatin alone.
According to lead author of the study, Nicholas J. Vogelzang, M.D., University of Chicago Cancer Research Center, "This is the largest clinical trial ever conducted in this disease and the 25 to 30 percent improvement in survival for patients on the combination therapy is the first time anyone has documented a significant improvement in patients treated for mesothelioma."
Under the current expanded access program, Alimta may be available free to patients who qualify. Additionally, patients with mesothelioma may be entitled to large settlements against employers or asbestos makers.
If you would like more information about Mesothelioma or your legal rights please contact us here.
0 comments:
Post a Comment