FDA Approves Lilly Drug for Asbestos Related Cancer

 
February 5, 2004 the FDA approved Eli Lilly's alimta as the first FDA approved treatment for mesothelioma believed to have 15,000 patients around the world.

According to Lilly, Alimta was approved by the FDA when used with cisplatin, a common chemotherapy. Currently nearly 70 percent of patients with mesothelioma are not candidates for surgery.

Mesothelioma, attacks a membrane that covers and protects internal organs. About 3,000 people in the United States are diagnosed each year with this cancer, which results from past exposure to asbestos.

Alimta gives patients several additional months of life, but promises long life with this cancer.

According to news reports, Paolo Paoletti, a senior Lilly research executive stated: "This is a unique first step against this very resistant tumor," he also said that the company recently asked U.S. regulators to also approve the drug for treatment of non-small-cell lung cancer.

Patients usually do not learn they have mesothelioma until the disease has progressed to an advanced stage, when treatment with surgery or radiation is not an option.

A clinical trial of 448 patients showed patients taking Alimta plus cisplatin survived on average 12.1 months, compared with 9.3 months in patients taking cisplatin alone.

The cancer typically develops decades after a person has been exposed to asbestos --once widely used to insulatation, on board ships and for other uses, such as brake linings and fireproofing materials.

Alimta was has been awarded coveted "orphan drug" status by the FDA, which gives Lilly exclusive U.S. marketing rights to the product for seven years. The Orphan drug FDA designation is granted for treatments with fewer than 200,000 patients.

Eli Lilly is also studying Alimta, which blocks several enzymes that help cancer cells grow, for treatment of other cancers.

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