- Celgene's Abraxane (nab-paclitaxel) is now approved in the E.U. for first-line treatment in combination with carboplatin in adults who are not eligible for radiation or surgery.
- Non-small cell lung cancer (NSCLC) is the type of cancer that 85% to 90% of all people with lung cancer have. Most lung cancer is caused by cigarette smoking, although some cases are caused by environmental factors.
- The approval is based on positive results from a phase III trial involving 1,052 chemotherapy-naive patients with stage IIIb/IV NSCLC.
In Celgene's phase III trial, which was used to gain approval of Abraxane for first-line treatment of patients with advanced NSCLC, overall response rate for Abranxane treatment was 33% versus 25% in the control group—a significant difference. Abraxane is now approved in both the U.S. and the E.U. for treatment of several hard-to-treat tumor types, including not only advanced NSCLC, but also metastatic breast cancer and pancreatic cancer.
Abraxane, which was first approved for oncologic use in 2005, is a nanotechnology agent that is the only albumin-based nanotechnolgy therapy approved for these indications.