Celgene’s Abraxane Gets Third EU Cancer Indication

European regulators have granted Celgene’s nanotechnology-based therapy Abraxane its third cancer indication as a first-line treatment alongside carboplatin for non-small cell lung cancer patients who don’t qualify for surgery or radiation therapy.

Abraxane (nab-paclitaxel) is the first albumin-based nanotechnology approved for metastatic breast cancer, pancreatic cancer and NSCLC in Europe, the U.S. and other markets around the world, Celgene says. It works by binding nanoparticles made from the chemotherapy drug paclitaxel in albumin, which is a protein.

This eliminates the need to administer steroids before chemotherapy and lets doctors deliver more and higher doses of the drug cocktail than with conventional paclitaxel, Celgene spokeswoman Julissa Viana said.

In a clinical trial of 1,052 patients with stage IIIb/IV NSCLC, 33 percent in the nano-Abraxane/carboplatin arm achieved gains in overall response rate, compared with 25 percent of patients in the conventionally formulated arm.

Abraxane has garnered three approvals each in the U.S. and EU since January of 2005: as a second-line treatment for metastatic breast cancer, as a first-line treatment for locally advanced or metastatic NSCLC and for metastatic pancreatic cancer alongside gemcitabine.

The drug is also available for NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, Singapore and New Zealand. Plans to expand further into Asia and South America are ongoing, Viana says. — Lena Freund