Mersana Therapeutics (NASDAQ:MRSN) has announced that the FDA has granted an additional fast track designation (FTD) to its emiltatug ledadotin (XMT-1660) for the treatment of advanced or metastatic breast cancer.
The company also announced that the World Health Organization (WHO) has approved emiltatug ledadotin (abbreviated as Emi-Le) as XMT-1660’s international non-proprietary name (INN). The FDA previously granted FTD to Emi-Le for the treatment of adult patients with advanced or metastatic recurrent triple-negative breast cancer (TNBC).
“Topoisomerase-1 inhibitor ADCs are rapidly becoming the standard of care for metastatic TNBC and hormone-receptor positive breast cancer, and an increasing amount of research shows that these patients are exceedingly difficult to treat thereafter,” said Martin Huber, MD, president and CEO of Mersana Therapeutics.
“This growing population is a primary focus for us as we advance the development of Emi-Le. We are excited to announce this additional FTD and the initial clinical data from our ongoing Phase 1 clinical trial that were press released separately this morning,” Dr. Huber added.
