Biopharmaceutical company Genta Inc. focuses on innovative products for cancer treatment. The U.S. Food and Drug Administration (FDA) has granted Genta’s request for Fast Track designation of the company’s late phase 2 oncology product tesetaxel for treatment of patients with advanced gastric cancer.
The FDA grants Fast Track designation in order to accelerate the review of new drugs that are intended to treat serious or life-threatening conditions. The designation typically opens the door for the company to submit New Drug Application (NDA) on a “rolling” basis with ongoing FDA review during the submission process.
In the completed phase 2a study, patients with advanced gastric cancer were treated with tesetaxel once every three weeks, which resulted in a major response rate of 20 percent and a disease-control rate of 60 percent. Based on the positive phase 2a trial results, Genta is conducting a confirmatory phase 2b trial of tesetaxel as 2nd-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen.
The company has also developed a trial design and clinical protocol for a phase 3 trial of tesetaxel, which it plans to submit to the FDA in the second quarter in order to secure a Special Protocol Assessment (SPA).
Shares of Genta soared nearly 50 percent in early trading, spurred by today’s news.