FDA Grants Fast-Track Status to Genta’s, Allon’s Drugs

The FDA has granted fast-track status to Genta’s gastric cancer treatment tesetaxel and Allon Therapeutics’ neuroprotective drug davunetide. Genta expects to submit its plan for a randomized, double-blind, placebo-controlled Phase III trial to the FDA in the second quarter, the company said last week. Genta has completed a dose-ranging and pharmacokinetic study of tesetaxel plus Roche’s Xeloda (capecitabine).
Washington Drug Letter