Celgene Gains New FDA Approval for Abraxane
Oct 12th 2012 3:47PM
Updated Oct 12th 2012 3:54PM
Celgene (NAS: CELG) announced today that the U.S. Food and Drug Administration approved use of Abraxane for first-line treatment of non-small cell lung cancer in combination with the chemotherapy drug carboplatin. The announcement follows a successful phase 3 study where Abraxane compared favorably against existing treatment options.
Abraxane was first approved in the U.S. in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.
Non-small cell lung cancer accounts for 87% of all lung cancer cases, according to information provided by the company.
Dr. Mark A. Socinski from the University of Pittsburgh served as the lead investigator for the Abraxane phase 2 and 3 lung cancer studies. The drug "offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years," he said in a company press release.
Celgene has also submitted applications for use of Abraxane in Australia, Japan, and New Zealand. The company expects decisions by regulatory agencies in these countries in 2013.
Net product sales of Abraxane were more than $385 million in 2011.
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