FX.co ★ Mersana Therapeutics: FDA Grants Additional Fast Track Designation To XMT-1660

Mersana Therapeutics (MRSN) recently revealed that the FDA has granted an additional Fast Track designation to XMT-1660. This new designation pertains to the treatment of advanced or metastatic breast cancer in patients with either low human epidermal growth factor receptor 2 (HER2) levels or HER2-negative disease. Furthermore, the World Health Organization has approved the international nonproprietary name for XMT-1660, which is emiltatug ledadotin.

In a separate announcement, Mersana Therapeutics disclosed encouraging initial clinical results from the Phase 1 dose escalation and backfill cohorts for emiltatug ledadotin. This compound is Mersana's leading Dolasynthen antibody-drug conjugate (ADC) candidate targeting B7-H4.

"We are enthused by the initial safety, tolerability, and efficacy data for Emi-Le, which demonstrate an exciting and distinctive profile within the B7-H4 field and the broader ADC landscape," stated Martin Huber, CEO of Mersana Therapeutics.