Xyotax is a biologically-enhanced version of Bristol-Myers Squibb’s anticancer drug Taxol, often used in the treatment of ovarian, breast, and non-small cell lung cancer (NSCLC).
Fast track designation was granted to Xyotax because NSCLC in poor performance status patients is incurable with available therapy offering only modest benefit, and Xyotax has the potential to demonstrate improvement over available therapy in these patients.
Fast tracked drugs are subject to accelerated review, with the FDA bound to announce a decision on the approval of the drug within six months of the submission of the application.
Based on preclinical studies, it appears that Xyotax is preferentially trapped in the tumor blood vessels allowing significantly more of the dose of chemotherapy to localize in the tumor. Preclinical and clinical studies also support that Xyotax metabolism by lung cancer cells may be influenced by estrogen which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.