Following feedback from the U.S. Food and Drug Administration (FDA) in a pre–new drug application meeting, Odonate Therapeutics has concluded that the clinical data package for tesetaxel, an oral taxane tested in patients with metastatic breast cancer, is unlikely to support FDA approval. Therefore, it is discontinuing the development of tesetaxel and will close the company's operations. Odonate will work with clinical sites to transition patients in ongoing tesetaxel clinical studies to appropriate alternative therapies.
“We thank the investigators, study team personnel, and especially the patients and their caregivers for their endeavors to improve treatments for patients with breast cancer,” said Kevin Tang, Chief Executive Officer of Odonate.
