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Celgene’s Abraxane receives FDA approval in lung cancer

Adds to current breast cancer indication

Celgene can now market its breast cancer drug Abraxane in the US for treatment of non-small cell lung cancer (NSCLC) after receiving an additional approval from the Food and Drug Administration (FDA).

Abraxane is already available to treat patients with metastatic breast cancer who have failed to respond to other treatments, but can now be used for the first-line treatment of locally advanced or metastatic NSCLC, in combination with carboplatin, in patients who are unable to undergo surgery or radiation therapy.

The approval opens up a new market for the drug, which achieved revenues of $168m during the first six months of 2012 in its current indication. Analysts have said its performance in lung cancer could add more than $100m to these annual sales.

Abraxane combines the chemotherapy paclitaxel with the protein albumin in order to improve the delivery of the active ingredient to cells.

In a phase III trial, Abraxane was able to reduce tumour size in 33 per cent of patients, while paclitaxel used without the albumin only managed to reduce tumour size in 25 per cent. Both arms of the trial studied the drug in combination with carboplatin.

Dr Mark Socinski, director of the lung cancer section in the division of heamatology/oncology at University of Pittsburgh, and lead investigator of the Abraxane trials, held the FDA approval as another step in fighting what is the leading cause of cancer death in the US.

“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 in Japan, Australia and New Zealand, with decisions anticipated at some point during 2013.

The drug is also currently in various stages of investigation for the treatment of several other cancers, including pancreatic, metastatic melanoma, bladder, ovarian, and expanded applications for breast cancer.

15th October 2012

From: Sales, Marketing, Regulatory



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