The FDA OK’d Celgene’s Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. The drug was approved for use in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Mark A. Socinski, M.D., director, lung cancer section, division of hematology/oncology, University of Pittsburgh, and lead investigator of Abraxane Phase II and Phase III lung cancer trials. “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.”

Celgene has filed additional regulatory submissions for the product in Japan, Australia, and New Zealand. This approval marks the second indication for Abraxane in the U.S. where the drug was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.

According to Genomic Health, the incidence of non-small cell lung cancer totals about 171,000 cases per year.

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