The European Commission (EC) has granted approval for Celgene International Sàrl’s Abraxane (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel) in combination with carboplatin as a first-line treatment of non-small cell lung cancer (NSCLC) in adult patients.
Approval for the new indication allows the company to market the drug for NSCLC across 28 member states in the European Union (EU). It has already been approved to treat metastatic pancreatic and breast cancers.
Abraxane is a nanotechnology agent, which is currently the only albumin-based nanotechnology therapy approved to treat metastatic breast cancer, NSCLC and pancreatic cancer in the US, Europe and other markets across the globe.
Celgene Europe, Middle East and Africa (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 approval was based on the positive opinion of Medicinal Products for Human Use (CHMP) and results of a multicentre, randomised and open-label study, including 1,052 chemotherapy-naive patients with Stage IIIb/IV NSCLC.
The trial compared Abraxane, in combination with carboplatin against solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients, with advanced NSCLS who are not candidates for potentially curative surgery or radiation therapy.
According to the company, the primary efficacy endpoint, including overall response rate, was significantly higher for patients in the Abraxane /carboplatin arm at 33% compared with patients in the control arm at 25%.
Abraxane was first approved in 2005 by the US Food and Drug Administration (FDA) to treat breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy.
Currently, the drug has received approval in around 50 countries to treat metastatic breast cancer.
Image: Endobronchial radiation therapy for non-small cell lung cancer. Photo: courtesy of Tdvorak.