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Celgene gets FDA green light for Abraxane in lung cancer

Daily News | October 13, 2012

Kevin Grogan

Celgene gets FDA green light for Abraxane in lung cancer

Celgene Corp is celebrating after regulators in the USA gave a second approval to Abraxane, this time for lung cancer.

The US Food and Drug Administration has given the green light to Abraxane (nanoparticle albumin-bound -'nab' - paclitaxel)) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer. It is approved for use in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Abraxane was first approved in the USA in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy. It was developed by Abraxis Bioscience, which Celgene bought in a deal valued at $2.90 billion in 2010.

The latest approval is based on a Phase III trial which saw 521 patients with advanced NSCLC receive either Abraxane (100mg/m2) weekly plus carboplatin every three weeks or paclitaxel (200mg/m2) every three weeks plus carboplatin, which was given to 531 patients. The study met its primary endpoint demonstrating a statistically significantly higher overall response rate for patients in the Abraxane arm compared to those in the paclitaxel arm (33% vs 25%).

Mark Socinski of the University of Pittsburgh and lead investigator of the Abraxane lung cancer programme, noted that NSCLC is the leading cause of cancer death in the USA so the approval "is exciting for healthcare professionals because it offers an important new treatment option" in an area that has seen few advancements in recent years. Additional regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.

These are heady times for Abraxane; earlier this month, Celgene presented late-stage data showing that the drug helps melanoma patients live longer without their disease progressing. Observers are also eagerly waiting for results from a Phase III trial in pancreatic cancer before the end of the year.

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