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Cancer treatment Abraxane gets EU nod

pharmafile | January 9, 2014 | News story | Sales and Marketing Abraxane, Cancer, Celgene, EU, pancreatic 

Celgene’s cancer drug Abraxane has been approved by European regulators to treat patients with metastatic adenocarcinoma of the pancreas, or metastatic pancreatic cancer – conditions which have high mortality rates.

Abraxane (paclitaxel formulated as albumin bound nanoparticles, or nab-paclitaxel) is a hi-tech version of paclitaxel and the European Commission has decided it can be used with gemcitabine for first-line treatment of adults.

The new formulation binds the drug to protein particles, allowing the chemotherapy to target tumours more effectively.

The drug was given ‘priority review’ status by European and US authorities: last September, the FDA approved Abraxane as first-line treatment for patients with metastatic adenocarcinoma of the pancreas, again with gemcitabine.

The EC decision was based on the results of the Phase III MPACT trial, which showed the combination demonstrated a statistically significant improvement in median overall survival compared to gemcitabine alone (8.5 months versus 6.7 months).

In June last year, Celgene predicted that Abraxane would be one of three new blockbusters expected to break the $1 billion barrier if approved – and it is banking on a relative lack of progress in treating cancer of the pancreas to achieve this with Abraxane.

The firm says that since 1990, more than 30 Phase III trials have failed to lead to regulatory approval in Europe for advanced or metastatic pancreatic cancer: the European Cancer Observatory said 78,654 people were diagnosed with pancreatic cancer in the EU in 2012, with 77,940 dying the same year.

“With such low survival rates for this disease, the situation for patients and their families is really very poor,” said Josep Tabernero, head of medical oncology at the Vall d’Hebron University Hospital in Barcelona, and a primary investigator for the MPACT trial.

Alan Colowick, president of Celgene Europe, the Middle East and Africa, said: “Abraxane in combination with gemcitabine is the first treatment in Europe to be approved for pancreatic cancer in nearly seven years. We remain committed to developing innovative treatments to improve the lives of those with this devastating disease.”

The drug was approved in January 2008 in Europe as monotherapy for metastatic breast cancer (MBC) in adults who have failed first-line treatment for metastatic disease, and for whom standard, anthracycline containing therapy is not indicated.

Abraxane is approved in the US for breast cancer and non-small cell lung cancer.

Adam Hill 

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