Historically, metastatic bladder cancer has been “a very bad prognosis,” in the words of Seattle Genetics CEO Clay Siegall. But his company and partner Astellas now have a shot at trying to change that.
Wednesday, the FDA handed the duo an early approval for Padcev, a first-of-its kind antibody-drug conjugate. The product targets Nectin-4, a protein on the surface of cells that’s highly expressed in bladder cancer, and it’s now cleared for patients who have already received chemo and a checkpoint inhibitor from the PD-1/PD-L1 class.
Regulators based their decision on data from a phase 2, single-arm study known as EV-201. That trial showed Padcev could shrink tumors in 44% of patients and eliminate them in 12%.
A full course of Padcev cost between $110,000 and $120,000, Seattle Genetics estimates, with the final tally varying based on a patient’s weight and how long he or she stays on treatment. The net price, though, will be closer to $90,000 because of government discounts for older patients, Siegall said.
While “we understand it’s expensive, it’s a reasonable price when you look at the world of cancer therapies that have come out” recently, with some of them ranging up to $200,000, he said. The company tried to “do what we thought was a fair job at assessing this in a way that payers would see the value and the cost and think it was appropriately priced,” he added.
Meanwhile, the drug should be available to patients within two days of launch, Siegall said, noting that the company's goal was to be “launch-ready in November.” The partners will field just over 100 sales reps, with a “full complement of activity for commercial to complement and support with marketing and reimbursement and medical affairs.”
“We will be out in full force from approval,” Siegall said, adding that “we think there will be good uptake of this drug.”