CELL THERAPEUTICS WILL SEEK CANCER DRUG APPROVAL

Cell Therapeutics plans to seek U.S. and European approval to market an experimental treatment for an advanced stage of lung cancer. The company said it will submit a new drug application to the FDA for Xyotax, as first-line monotherapy for women with advanced non-small cell lung cancer.

In May, the company said late-stage trials of Xyotax missed a main goal of showing superior survival rates in patients on the treatment compared with those taking existing treatments. The trials, known as STELLAR 2 and 4, both demonstrated equivalent survival with significant reductions in serious side effects when compared to alternative drugs docetaxel or gemcitabine/vinorelbine.

Xyotax links paclitaxel, the generic form of Bristol-Myers Squibb's Taxol, to a substance that binds to tumors, with the goal of reducing damage to healthy cells as well as side effects like nausea and hair loss.