The drug, Alimta, from Eli Lilly and Company, today received FDA approval for use in combination with cisplatin chemotherapy. It will be used to treat malignant mesothelioma. It strikes some 2,000 Americans each year, mostly due to asbestos exposure. Worldwide, as many as 15,000 people each year are told they will die of mesothelioma.
It's a terrible disease. Tumors grow on the outer lining of the lung. They squeeze the lung, causing pain and making it hard to breathe. Symptoms don't appear until the cancer is very advanced. Most patients survive only nine to 13 months after diagnosis.
"Until now, when a patient was diagnosed with this disease, the oncologist said, 'Go home.' There was no treatment. There have been 50 failed attempts with other drugs to find some hope," Paolo Paoletti, MD, Lilly vice president for oncology, clinical research, and oncology products, tells WebMD.
In a clinical trial, most patients who added Alimta to their chemotherapy regimens survived at least 12 months. Half of these patients were still alive a year after treatment, while only a third of patients treated with chemotherapy alone survived this long.
Alimta is a toxic drug. But Paoletti says that by giving patients large doses of B vitamins, most of the toxicity is avoided.
"Usually chemotherapy is associated with a high level of toxicity," Paoletti says. "This drug does not have that. By adding low-dose folic acid and vitamin B-12 we significantly reduce the toxicity."
Lilly tells WebMD the drug should be available to pharmacies within a month. Meanwhile, Lilly will make the drug available to all mesothelioma patients.
Currently, the FDA approves Alimta only for mesothelioma. But studies are under way to see if the drug can help a large number of other tumors, including cancers of the lung, pancreas, breast, colon, stomach, and bladder.
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