FDA Expands Celgene's Abraxane Label

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Celgene Corporation (CELG) announced that it has received approval from the U.S. Food and Drug Administration (:FDA) for a label expansion of its cancer drug, Abraxane.

Celgene gained approval for Abraxane as a first-line therapy in patients suffering from metastatic adenocarcinoma of the pancreas in combination with Eli Lilly and Company’s (LLY) Gemzar. The FDA approval for the new indication came on the basis of encouraging data from a phase III study (MPACT: n=861). The FDA clearance marks the first approval of a drug for the above indication in nearly eight years.

We remind investors that Celgene filed for approval of the additional indication of Abraxane in Mar 2013. The FDA reviewed the application on a priority basis, which implied a six-month review period. The FDA, however, cleared the drug for the additional indication a couple of weeks before the assigned target date of Sep 21, 2013. We note that Abraxane in combination with Gemzar is also under review in the EU for the advanced pancreatic cancer indication. Abraxane is also under review in many other countries for the indication.

We note that this is the third indication for which Abraxane has been approved. Abraxane is already available as a second-line therapy for metastatic breast cancer. Last year, the drug was cleared by the FDA as a first-line combination therapy for treating patients suffering from locally advanced or metastatic non-small cell lung cancer. The FDA approval for the advanced pancreatic cancer indication has boosted the drug’s sales potential.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Actelion Ltd. (ALIOF) and Gilead Sciences Inc. (GILD) appear well placed in the biopharma space with a Zacks Rank #1 (Strong Buy).

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