Celgene receives ‘positive CHMP opinion for Abraxane’

Celgene's Abraxane has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).

In combination with carboplatin, the drug has been approved for the first-line treatment of non-small cell lung cancer (NSCLC) in adult patients that are not candidates for curative surgery or radiation therapy.

Lung cancer is the fourth most commonly diagnosed cancer in both men and women, and is the leading cause of cancer-related deaths in Europe.

NSCLC is the most frequently occurring form of lung cancer, accounting for 85 percent to 90 percent of all cases. It is caused mainly by smoking, although environmental and occupational factors can also cause the disease.

Treatment options usually include systemic chemotherapy or protein kinase inhibitors, but with the most advanced cases the symptoms can only be managed, clearly demonstrating the need for new therapies.

Dr Mary O’Brien, consultant medical oncologist at The Royal Marsden NHS Foundation Trust, UK, said: "The positive CHMP opinion for Abraxane in combination with carboplatin for the treatment of adult patients with NSCLC is a significant step toward bringing a new treatment option to patients in Europe."

She added that clinical data shows there is a significant response rate on patients, combined with an established safety profile.