Posted by Michael Wonder on 30 Aug 2017
FDA grants breakthrough therapy designation to Daiichi Sankyo’s DS-8201 for HER2-positive metastatic breast cancer
29 August 2017 - Designation based on preliminary clinical evidence highlights that DS-8201 has the potential to offer substantial clinical benefit to patients with a high unmet medical need.
Daiichi Sankyo today announced that the U.S. FDA has granted breakthrough therapy designation to DS-8201, an investigational HER2-targeting antibody drug conjugate, for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine.
The breakthrough therapy designation was granted based on the results of the ongoing phase 1 study assessing the safety, tolerability and preliminary efficacy of DS-8201. In the phase 1 study, no dose limiting toxicities were observed, and the maximum tolerated dose was not reached. Preliminary results of DS-8201 from a subgroup analysis of HER2-expressing metastatic breast cancer pre-treated with trastuzumab, pertuzumab and T-DM1 were recently presented at the 2017 American Society of Clinical Oncology (ASCO) annual meeting.
