Switzerland-based Celgene International has received approval from the European Commission (EC) for ABRAXANE plus gemcitabine combination therapy for first-line treatment of adult patients with metastatic pancreatic cancer.
The approval is based on the results of the Metastatic Pancreatic Adenocarcinoma Clinical Trial or MPACT, an open-label, Phase III, randomised, international trial.
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Celgene Europe, Middle East and Africa (EMEA) president Alan Colowick said ABRAXANE is the first treatment in Europe to be approved for pancreatic cancer in nearly seven years.
"Since 1990, more than 30 Phase III trials have failed to lead to regulatory approval in the European Union for advanced or metastatic pancreatic cancer," Colowick said.
"This announcement is a significant step forward, but it is by no means the end for Celgene. We remain committed to developing innovative treatments to improve the lives of those with this devastating disease."
The MPACT trial included 861 chemotherapy-naïve patients with metastatic pancreatic cancer at 151 community and academic centres from 11 countries, including North America, Eastern and Western Europe, and Australia.
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By GlobalDataIn the trial, ABRAXANE plus gemcitabine showed significant improvement in median overall survival compared witht gemcitabine alone; a 28% overall reduction in risk of death.
According to the company, grade 3 and higher adverse events were reported more often with ABRAXANE plus gemcitabine, over gemcitabine alone, were neutropenia, fatigue and peripheral neuropathy.
The approval follows the positive opinion issued by the Committee for Medicinal Products for Human Use in November 2013.
The company said that in the last few decades, little progress has been made in improving outcomes for patients diagnosed with pancreatic cancer.
In 2012, 78,654 people were diagnosed with pancreatic cancer in the EU and 77,940 died, according to the European Cancer Observatory.
Vall d’Hebron Institute of Oncology head of the Medical Oncology Department and primary investigator for the MPACT trial Josep Tabernero said: "With such low survival rates for this disease, the situation for patients and their families is really very poor.
"But now, we have been able to show that the addition of nab-paclitaxel to conventional treatment with gemcitabine provides substantial benefits in overall survival, with manageable side effects."
Under the local requirements, ABRAXANE will be launched in the European Union in the coming months.
In September 2013, the FDA approved ABRAXANE as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.
Image: No new medications were approved for pancreatic cancer in nearly seven years. Photo: courtesy of freedigitalphotos.net.
