FDA ‘Breakthrough’ status for raludotatug deruxtecan

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for Merck & Co’s (NYSE: MRK) raludotatug deruxtecan (R-DXd) for the treatment of adult patients with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior treatment with bevacizumab.

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TYO: 4568) and being jointly developed by Merck, under a 2023 deal,potentially worth $22 billion to the Japanese firm.

The FDA BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The medicine is required to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over currently available medicines.