That didn't take long: Shortly after Seagen and Astellas Pharma's Padcev nabbed a priority review for two bladder cancer applications, the FDA has returned with double green lights—and it's given the OK more than a month ahead of schedule.
First up, Padcev's conditional nod in third-line metastatic or locally advanced bladder cancer has been converted into a full approval. Until now, the drug has carried an accelerated approval to treat patients who've already received platinum-based chemotherapy and a PD-1/PD-L1 checkpoint inhibitor.
At the same time, the FDA blessed the antibody-drug conjugate's move into earlier bladder cancer treatment as a second-line therapy for adults who are ineligible for cisplatin-based chemotherapy.
“Almost half of advanced bladder cancer patients cannot receive cisplatin-based chemotherapy," Evan Yu, M.D., a member the University of Washington School of Medicine's oncology division and lead investigator for Padcev's EV-201 study in cisplatin-ineligible patients, said in a statement. Many of those patients receive an immunotherapy first, and if that treatment falls short, they're left with few other options, he said.
Padcev's swift trip through the FDA came courtesy of the agency's Real-Time Oncology Review pilot, which aims to hasten reviews for certain cancer meds so they can reach patients faster. The regulator handed Seagen and Astellas' Padcev applications a priority review tag in April and wasn't expected to make a decision until Aug. 17.
The FDA granted its full approval on data from the partners' late-stage EV-301 trial, which showed at the time of a prespecified interim analysis that patients treated with Padcev lived a median of 3.9 months longer than those on chemotherapy. Specifically, the Padcev arm yielded a median overall survival time of 12.9 months versus the chemotherapy cohort's nine months, Seagen and Astellas said.
As for the second-line green light in cisplatin-ineligible patients, data from a second cohort from Padcev's EV-201 study showed the drug triggered a response in 51% of patients after a median follow-up of 16 months. Those responses lasted for a median of 13.8 months, Seagen and Astellas said.
Padcev's new approvals put the drug one step closer to its blockbuster ambitions. SVB Leerink's Andrew Berens has said the med could hit $1.32 billion in peak sales across all its potential nods in previously treated bladder cancer. Meanwhile, Wall Street predicts that number could swell to $2.8 billion in 2030—provided Padcev makes its way up the treatment chain to newly diagnosed bladder cancer patients.
To reach that goal, Seagen and Astellas are pairing Padcev with Merck's immuno-oncology megablockbuster Keytruda in a cohort of their phase 2 EV-103 trial, which is looking at cisplatin-ineligible patients. They're also eyeing front-line use with Keytruda in their late-stage EV-302 study, which is pitting the combo against chemotherapy in patients regardless of cisplatin eligibility.