Celgene’s lung cancer drug Abraxane gets approval in Europe

Manufactured using patented nab technology, Abraxane (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) is approved to treat NSCLC patients who are not candidates for potentially curative surgery and/or radiation therapy.

It is a nanotechnology agent and the only albumin-based nanotechnology therapy currently approved to treat metastatic breast cancer, non-small cell lung cancer and pancreatic cancer in the US, Europe and other markets worldwide.

Celgene EMEA president Tuomo Pätsi said: "At Celgene, we are pleased that the EC’s approval of Abraxane in NSCLC allows patients in Europe who have been diagnosed with this devastating disease to access this innovative nanotechnology medicine.

"The expanded application of Abraxane across three difficult to treat tumors – breast, pancreatic and lung cancers – reinforces the value Abraxane provides and our commitment to advance transformational science, deliver life-enhancing medicines and serve patients with cancers the world over."

The EC decision follows the positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

The approval is based on data from a multicenter, randomized, open-label trial which included 1,052 chemotherapy-naive patients with Stage IIIb/IV NSCLC.

In the trial, Abraxane was compared in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in these patients.

The company said that the primary efficacy endpoint, overall response rate, was significantly higher for patients in the Abraxane/carboplatin arm at 33%, compared with patients in the control arm, at 25%.