FDA Approved ALIMTA^® (Pemetrexed) in 2004

Mesothelioma News

ALIMTA^® (Pemetrexed) Study Indicated Drug’s Effectiveness in Treating Pleural Mesothelioma

INDIANAPOLIS, IN — November 22, 2006 — A large study conducted at multiple medical facilities confirmed the usefulness of treating pleural mesothelioma patients with ALIMTA^® (pemetrexed) plus cisplatin, according to its authors (Lung Cancer, 2006 Nov 6). They found that 67% of the study participants receiving the combination treatment either experienced some tumor reduction or their disease stabilized.

Seven hundred twenty–eight patients with pleural mesothelioma received ALIMTA^® and cisplatin every 21 days for several cycles as well as daily doses of the B vitamin folic acid. Their ages ranged from 23 to 89 years, with a median age of 70 years. None of the patients had previously received chemotherapy. None had been considered for surgery, since their cancer was too widespread.

The researchers were able to gather data for 615 patients. Among this group, 20% had tumors that responded to the ALIMTA^®/cisplatin treatment. The median survival was 10.8 months. Side–effects included dehydration, nausea, vomiting, breathing problems and blood clots.

The manufacturer of ALIMTA^®, Eli Lilly, sponsored the study. According to the researchers, the study was limited by the fact that there was no comparison or control group, which would have included patients with pleural mesothelioma who received fake pills rather than ALIMTA^® and cisplatin. Nevertheless, the researchers concluded that the study results “tend to confirm, in a community population, the usefulness of the combination of pemetrexed and cisplatin against malignant pleural mesothelioma.”

ALIMTA^®’s History

ALIMTA^® attacks cancer cells by inhibiting the synthesis of thymidine and purine, enzymes that are necessary for cell growth. Cisplatin is a platinum compound that has been used as a standard chemotherapy drug for cancer.

The Food and Drug Administration (FDA) approved the combination of ALIMTA^® and cisplatin in 2004 to treat pleural mesothelioma patients with more advanced disease who were not good candidates for surgery. The study tracked patients who were part of an “expanded accessibility program,” which gave treatment to patients from May 2002 until February 2004, when the drug was officially approved.

In July of this year, the FDA modified the label for ALIMTA^® to warn that the drug could suppress bone marrow function. This could result in anemia (low red blood cell count), neutropenia (decrease in the number of certain white blood cells) and thrombocytopenia (a decrease in the amount of platelets in the blood). The FDA advises doctors to be aware of these complications in mesothelioma patients taking ALIMTA^®, to perform the appropriate tests and to adjust the dosage of ALIMTA^® accordingly.

Mesothelioma and Your Legal Rights

For further details about mesothelioma treatment, see Pleural Mesothelioma: Choosing a Treatment that Is Right for You. Also see Mesothelioma Treatment: Chemotherapy and New Drug Research. If you or a loved one has been diagnosed with mesothelioma, please feel free to contact us at Brayton Purcell to learn about your legal choices. We have been handling cases involving pleural mesothelioma and asbestos exposure for over 20 years and can provide support, information, and excellent advocacy.