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FDA approves Celgene's Abraxane for lung cancer

Source: Thomson Reuters Foundation - Fri, 12 Oct 2012 14:15 GMT
Author: Reuters
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Oct 12 (Reuters) - U.S. health regulators on Friday widened the approved use of Celgene Corp's breast cancer drug Abraxane to include treatment for non-small cell lung cancer, the most common form of lung cancer.

Abraxane is currently approved to treat patients with metastatic breast cancer who have failed to respond to other treatments. Celgene hopes to win approval to market it for several other types of cancer, including pancreatic cancer and melanoma.

Celgene, whose shares rose as much as 2.6 percent Friday morning, acquired Abraxane when it bought Abraxis BioScience in 2010 for ${esc.dollar}2.9 billion, which some investors considered an excessively high price.

The drug combines the cancer chemotherapy paclitaxel with a protein called albumin, which Celgene believes helps deliver a greater amount of chemotherapy to cancer cells with fewer side effects.

A late-stage trial of Abraxane showed that tumors shrank in 33 percent of patients taking the drug along with standard chemotherapy treatment carboplatin compared with 25 percent of patients who took paclitaxel plus carboplatin.

Abraxane's peak annual lung cancer sales could eventually reach ${esc.dollar}110 million, according to a research note from Barclays on Thursday.

The company also said that it had filed for regulatory approval in Japan, Australia and New Zealand and expected decisions in 2013.

Celgene shares were up ${esc.dollar}1.88 at ${esc.dollar}79.60 in morning Nasdaq trading while the Nasdaq Biotech Index was little changed. (Reporting By Deena Beasley and Caroline Humer; Editing by Gerald E. McCormick & Theodore d'Afflisio)

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