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Headline: Lilly Gets Fourth FDA Approval for ALIMTA

A spokesperson for Eli Lilly and Co. (LLY), one of the leading US pharmaceutical manufacturers, released a statement last week that the US Food and Drug Administration (FDA) has granted a fourth approval for the cancer drug ALIMTA to be used as an upkeep therapy for locally advanced or metastatic non-small cell lung cancer (NSCLC).

NSCLC is among the most frequently occurring varieties of lung cancer. More than one hundred eighty thousand new cases are diagnosed each year in the US.

The company said that the most recent approval allows for the role of ALIMTA as a maintenance therapy for NSCLC, especially for those patients with nonsquamous tumors and in cases where the disease has not advanced after the patient has received up to four cycles of chemotherapy. ALIMTA is not suggested for use in treating patients with squamous cell non-small cell lung cancer.

Richard Gaynor, VP of cancer research and global oncology platform leader for Lilly, said this about the approval:

“It represents an important paradigm shift for NSCLC treatment – maintenance therapy as a way of extending survival in nonsquamous patients, using histology as a way of determining which NSCLC patients may benefit and which may not.”

The firm also commented that Dr. Chandra Belani, who holds the posts of both the deputy director of Penn State Cancer Institute at Penn State University’s S. Hershey Medical Center and the Miriam Beckner distinguished professor of medicine, delivered the outcomes from the worldwide trial at the yearly meeting of the American Society of Clinical Oncology’s on May 31 in Orlando.

The double-blind trial compared effectiveness concerning survival rates between a routine of ALIMTA plus the finest supporting care, and a routine with a combination of placebo with finest supporting care. In the 663 patients who participated in the trial, the results confirmed those of earlier studies examining the use of histology to custom-fit therapy routines for patients with severe nonsquamous NSCLC.

The company also mentioned that during 2004, ALIMTA obtained FDA approvals for combination therapy with cisplatin to care for patients that had contracted malignant pleural mesothelioma. In many cases, the disease is inoperable or many patients may not be strong enough to undergo surgery. The firm also received FDA approval for the use of ALIMTA as an individual agent for treating patients with locally advanced or metastatic NSCLC after the patient had received earlier chemotherapy treatments.

Last year, the combination of ALIMTA and cisplatin received FDA approval as a treatment method for locally advanced or metastatic NSCLC in cases where patients displayed nonsquamous histology. ALIMTA is currently approved as an individual agent for the treatment of cases of locally advanced or metastatic, nonsquamous NSCLC after earlier chemotherapy.

Lilly’s stock closed the pre-July Fourth holiday trading day at $33.90 on the New York Stock Exchange.

Source: http://www.rttnews.com/Content/BreakingNews.aspx?Node=B1&Id=997246%20&Category=Breaking%20News&pageNum=2592_2660_2