EMA grants orphan drug status to Genta Tesetaxel

Genta claims that Tesetaxel is a novel taxane that is administered by mouth as a capsule. The drug was developed with a goal of maintaining high anti-tumor activity while eliminating infusion reactions, reducing neuropathy and increasing patient convenience.

Reportedly, in experimental models, Tesetaxel has demonstrated high activity against tumors that are resistant to paclitaxel and docetaxel.

The drug has previously received orphan drug designation by the US Food and Drug Administration (FDA) for both gastric cancer and melanoma, as well as fast track designation by FDA for gastric cancer.