FDA 'Breakthrough' status for enfortumab vedotin in urothelial cancer

The US Food and Drug Administration has granted Breakthrough Therapy designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

The designation is a significant boost for the drug’s developers, Japan’s Astellas Pharma (TYO: 4503) and US biotech Seattle Genetics (Nasdaq: SGEN) and is seen as one of Seattle’s leading candidates. The latter’s share price edged up 1.33% to $51.63, while Astellas gained 1.44% to 1,590 yen.

Earlier this month, US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen subsidiary also gained FDA Breakthrough designation in urothelial (mostly bladder) cancer for its candidate erdafitinib.