Keytruda and Padcev get another fast approval

The US regulatory approval story behind Padcev and Keytruda has been defined by unusual speed, with filings based on the EV-302 and now EV-303 studies being cleared in a month or less. The FDA set the tone a couple of years ago when EV-302 delivered confirmatory evidence for full approval in first-line cisplatin-ineligible urothelial carcinoma, while also enabling label expansion into cisplatin-eligible patients. The agency had accepted that BLA in November 2023, and granted approval only two weeks later, nearly five months ahead of the PDUFA date. The newest approval, based on data in neoadjuvant and adjuvant cisplatin-ineligible muscle-invasive bladder cancer from the EV-303 trial, follows the same pattern, and has come over four months before the filing's 7 April 2026 PDUFA date. Here, the combination cut risk of recurrence, progression or death by 60% versus surgery alone, with median EFS not reached, compared with 15.7 months for surgery. Overall survival also favoured the combo, with a 50% reduction in risk of death. Despite a government shutdown that thinned FDA staffing the agency completed this review in about 30 days. Attention now turns to upcoming cisplatin-eligible perioperative data from EV-304, expected in the coming months, an indication where AstraZeneca's Imfinzi secured FDA approval earlier this year.

Selected Padcev trials

Note: MIBC=muscle-invasive bladder cancer. Source: OncologyPipeline.