Seattle City Wire

Astellas Pharma, Inc., and Seagen, Inc., recently submitted supplemental license applications to the U.S. Food and Drug Administration's (FDA) Real-Time Oncology Review (RTOR) pilot program for drugs to be used in the treatment of cancers.

Under the RTOR program, the FDA is attempting to get treatments to patients as quickly as possible by exploring efficiencies in the review process, according to Cision PRNewswire. 

"The FDA's review of our applications under Real-Time Oncology Review supports our efforts to expand PADCEV's availability as a treatment option for more patients as quickly as possible," Dr. Andrew Krivoshik, senior vice president and oncology therapeutic area head at Astellas, told Cision PRNewswire. 

One of the supplemental Biologics License Applications is for converting the approval for PADCEV (enfortumab vedotin-ejfv) from accelerated to regular. The second seeks to expand the current label to include patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and are ineligible for cisplatin.

"Locally advanced or metastatic urothelial cancer is an aggressive disease with limited treatment options," Krivoshik said, according to Cision PRNewswire.

The label expansion request was prompted by results from the second cohort of EV-201, according to the release. The phase 2 clinical trial evaluated PADCEV in patients with locally advanced or metastatic urothelial cancer who were ineligible for cisplatin and had received prior immunotherapy treatment.

"Advanced bladder cancer patients urgently need more treatment options," Dr. Roger Dansey, chief medical officer at Seagen, told Cision PRNewswire. "Based on recently presented clinical trial results, PADCEV could address a significant unmet need for more patients with advanced urothelial cancer after initial immunotherapy treatment."

Currently, PADCEV is only approved for use in the United States.