The FDA has granted accelerated approval to enfortumab vedotin-ejfv (Padcev®, Astellas Pharma) with pembrolizumab (Keytruda®, Merck) for treatment of locally advanced or metastatic urothelial carcinoma, specifically for patients who are ineligible for cisplatin-containing chemotherapy. "Both enfortumab vedotin and pembrolizumab are effective monotherapy treatments in patients with locally advanced or metastatic urothelial carcinoma," began Christopher Hoimes, Associate Professor of Medicine at t...

​A recent study reports that only 20% of cancer drugs granted accelerated approval by the FDA ended up showing clinical benefit in terms of overall survival. Because it can take many years to assess a drug's clinical benefit as demonstrated through measures such as overall survival, in 1992 the FDA instituted the Accelerated Approval regulations, which permit drugs that fill an unmet medical need for serious conditions to be approved based on a surrogate end point. A surrogate end point is not i...