The notification was made in response to the company’s submission of a complete response to a prior notice from the FDA that had placed the drug on ‘clinical hold’.
Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel.
Loretta Itri, Genta’s president, pharmaceutical development, and chief medical officer, said: “We have formulated an innovative development strategy that may enable tesetaxel to become the first oral taxane to receive regulatory approval. We look forward to promptly resuming clinical trials in the second half of 2008.”