Alimta To Help In Fight Against Mesothelioma
FDA OKs Alimta for Asbestos-Related Cancer
February 5, 2004
NEW YORK (Reuters)--Eli Lilly and Co. on Thursday said U.S. regulators have cleared one of its drugs as the first approved treatment for asbestos-related cancer, a condition diagnosed annually in as many as 15,000 people worldwide.
The Indianapolis-based company said Alimta was approved by the U.S. Food and Drug Administration for use with cisplatin, a standard chemotherapy, in the estimated 70 percent of patients with the cancer who are not candidates for surgery.
The cancer, called malignant pleural mesothelioma,attacks a membrane that covers and protects internal organs. An estimated 3,000 people in the United States are diagnosed every year with the cancer, from past exposure to asbestos.
As with many other widely used cancer drugs, Alimta gives patients only a few additional months of life.
"This is a unique first step against this very resistant tumor," said Paolo Paoletti, a senior Lilly research executive who noted that the company recently asked U.S. regulators to also approve the drug for treatment of non-small-cell lung cancer.
Lilly said 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 -- a mineral once used extensively to insulate homes and ships and for other uses, such as in brake linings.
Alimta was given "orphan drug" status by the FDA, giving Lilly exclusive U.S. marketing rights to the product for seven years following marketing approval. The designation is granted for treatments that affect no more than 200,000 patients.
Lilly in the past three months has won U.S. approvals for two other new medicines, anti-impotence treatment Cialis and Symbyax for bipolar disorder. Symbyax combines two widely used Lilly medicines, Prozac for depression and Zyprexa for schizophrenia.
Lilly is also studying Alimta, which blocks three enzymes that help cancer cells grow, for treatment of cancers of the pancreas, breast and colon.
Lilly's $1 billion-a-year drug Gemzar is already a standard treatment for lung and pancreas cancers.
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