FDA grants accelerated approval to Seagen and Merck's combo for bladder cancer treatment.

Seagen and Merck's combination therapy of Padcev and Keytruda has received FDA accelerated approval for the first-line treatment of bladder cancer in patients who are ineligible for cisplatin-containing chemotherapy. The approval is based on positive data from a multi-cohort study, and analysts estimate that the market for cisplatin-ineligible urothelial carcinoma is worth $2.5 billion to $3 billion globally. The approval could potentially push Padcev into a multibillion-dollar market just as Pfizer prepares to acquire Seagen for $43 billion.