It has been just reported that the FDA has finally approved a treatment for bladder cancer. Check out the following reports about this below.
FDA approves treatment for bladder cancer
A new first-line treatment option is now available for Americans suffering from locally advanced or metastatic bladder cancer.
The combination of enfortumab vedotin-ejfv (Padcev) and pembrolizumab (Keytruda) has been approved by the FDA, and has shown better outcomes than chemotherapy.
This treatment can be used for all patients, regardless of their cisplatin eligibility, as per the results of the study conducted.
It should be noted that this combination had previously received an accelerated FDA approval, but only for patients who were not eligible for cisplatin-containing chemotherapy.
“[The] FDA approval represents a paradigm change in the treatment of advanced bladder cancer and provides hope to the thousands of Americans impacted by this aggressive disease,” said Dr. Ahsan Arozullah, senior vice president and head of oncology development for Astellas, in a press release on Dec. 15.
“This achievement is notable, as it is the first regimen approved in advanced urothelial cancer that has demonstrated superiority to platinum chemotherapy, the gold standard of care for decades.”
In October, a groundbreaking trial was presented at the European Society for Medical Oncology (ESMO) revealing that the survival rate of advanced stage cancer patients who had not been previously treated was almost doubled by the combination of enfortumab vedotin-ejfv and pembrolizumab.
The trial, named the EV-302-KEYNOTE-A39 study, enrolled 886 patients with advanced bladder cancer who were randomly assigned to receive either the drug combination or platinum-based chemotherapy, the standard-of-care treatment for advanced-stage bladder cancer.
The research team was amazed by the results:
Patients treated with the drug combination had an overall survival rate of 31.5 months, compared to 16.1 months for those who received chemotherapy.
“As you know, we’ve never seen a survival signal before in urothelial cancer,” said Dr. Thomas Powles, director of Barts Cancer Center in London, at ESMO. “We’ve never beaten chemotherapy in the first-line setting. This is the first time we’ve achieved that goal.”
