Mersana Therapeutics: FDA grants additional Fast Track designation to XMT-1660

Mersana Therapeutics (MRSN) announced the U.S. FDA recently granted an additional Fast Track designation to XMT-1660. The company also announced that the World Health Organization has approved emiltatug ledadotin as XMT-1660’s international nonproprietary name. The new Fast Track designation is for the treatment of advanced or metastatic breast cancer in patients with human epidermal growth factor receptor 2 low or HER2-negative disease, including triple-negative breast cancer, who have received a prior topoisomerase-1 inhibitor ADC. Additionally, hormone-receptor positive patients should also have received or be ineligible for endocrine therapy. The FDA previously granted Fast Track designation to Emi-Le for the treatment of adult patients with advanced or metastatic recurrent TNBC.