The US Food and Drug Administration (FDA) has approved PADCEV (enfortumab), in combination with Keytruda (pembrolizumab) or Keytruda QLEX (pembrolizumab and berahyaluronidase), as a treatment for certain patients with bladder cancer.
The approval follows the publication of results from the phase 3 EV-303 clinical trial. The trial found that the probability of survival at two years was 79.7% for patients who received the combination, relative to 63.1% for patients treated with surgery only. It also found no new safety signals associated with the combination treatment.
The PADCEV-Keytruda combination has been approved as a perioperative treatment for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.
Bladder cancer is the ninth most common cancer worldwide, affecting more than 614,000 people each year globally, with an estimated 85,000 of those living in the US. MIBC makes up around 30% of all bladder cancer cases. Neoadjuvant cisplatin-based chemotherapy followed by surgery has been shown to prolong survival in patients with MIBC, but up to half of MIBC patients are ineligible to receive cisplatin, a statistic which demonstrates the need for an innovative new treatment.
“Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin,” said Matthew Galsky, an investigator in the EV-303 trial. “This approval, based on striking event-free and overall survival benefits, may represent an important practice-changing advance for these patients who’ve had no new options in decades.”
Jeff Legos, chief oncology officer at Pfizer, commented: “Today’s approval, granted months earlier than anticipated, ushers in a new era of treatment for cisplatin-ineligible patients with MIBC who have long been underserved by existing treatments.
“PADCEV plus pembrolizumab is the first and only FDA-approved perioperative treatment regimen to demonstrate a meaningful survival advantage compared to surgery alone, positioning it to reshape the treatment landscape and bring new hope to patients and families.”