Genta Incorporated announced that the US Food and Drug Administration (FDA) has granted the company’s request for “Fast Track” designation of tesetaxel for treatment of patients with advanced gastric cancer. Tesetaxel -- a late phase-2 oncology product -- is the leading oral taxane currently in clinical development.

Fast Track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The designation typically enables a company to submit a New Drug Application (NDA) on a “rolling” basis with ongoing US FDA review during the submission process. NDAs with Fast Track designation are also usually granted priority review by US FDA at the time of submission.

Based on promising results in a phase-2a trial, Genta is conducting a confirmatory phase-2b trial of tesetaxel as second-line treatment in patients with advanced gastric cancer who have failed a single 1st-line regimen. As defined, the 1st-line regimen must comprise a platinum-containing compound (cisplatin, carboplatin, or oxaliplatin) and a fluoropyrimidine (5-fluorouracil, capecitabine, or S-1). The Fast Track designation targets the patient population that is enrolling in the Phase 2b trial.

Genta has formulated a trial design and clinical protocol for a randomized, double-blind, placebo-controlled phase-3 trial of tesetaxel in this patient population. In developing the trial, the company completed a dose-ranging and pharmacokinetic study of tesetaxel plus capecitabine (Xeloda; Hoffmann LaRoche, Inc.). Results from that study showed that full doses of each of these orally administered drugs could be administered together without causing overlapping side-effects.

Genta plans to submit its proposed phase-3 trial to US FDA in the second-quarter in order to secure a Special Protocol Assessment (SPA). The company looks forward to meeting with the FDA to discuss the trial design.

Taxanes (including paclitaxel and docetaxel) are the most widely used chemotherapy drug class in cancer medicine.

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer.