Celgene's Abraxane Gets FDA Approval to Treat Non-Small Cell Lung Cancer
October 12, 2012
The FDA has approved Abraxane for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who aren't candidates for curative surgery or radiation therapy.
Mark A. Socinski, lead investigator of mid- and late-stage lunch cancer trails of Abraxane, noted that non-small cell is the most common type of lung cancer, and the leading cause of cancer death in the U.S.
"The FDA approval of Abraxane is exciting for healthcare professionals because it 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.
The approval is based on the results of a late-stage study of Abraxane that met its primary endpoint.
Non-small cell lung carcinoma is any type of epithelial lung cancer other than small-cell lung carcinoma. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented technology. It is formulated with albumin, a human protein, and is free of solvents.
The most recent approval marks the second indication for Abraxane in the U.S. Abraxane was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.
Earlier this month, Celgene said the primary endpoint was achieved in a late-stage investigational study of Abraxane in patients with metastatic melanoma.
In July, the drug company reported its second-quarter earnings rose 31% as it continued to report market share gains for its flagship drug Revlimid and sales of its Vidaza treatment continued to grow despite its loss of market exclusivity.
Shares were up 66 cents to $78.42 in recent trading. The stock is up 25% in the past three months.
CHEMO101.COM
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