EU Approves Padcev, Keytruda Combo for Bladder Cancer

The European Commission has given its approval to Astellas’ antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with Merck & Co.'s PD-1 inhibitor Keytruda (pembrolizumab) for the initial treatment of adults with unresectable or metastatic urothelial cancer who are not candidates for platinum-based chemotherapy. This decision aligns with the latest guidelines from the European Society for Medical Oncology (ESMO) and the European Association of Urology, which endorse this combination as a first-line treatment for patients with advanced or metastatic disease.

Ahsan Arozullah, the head of oncology development at Astellas, expressed optimism about the approval, anticipating that patients across the EU will benefit significantly from this combination at the onset of their treatment journey.

The approval from the European Commission follows a positive recommendation from the European Medicines Agency's (EMA) advisory panel last month. The decision was heavily influenced by the Phase III EV-302/KEYNOTE-A39 study, which compared the efficacy of Padcev combined with Keytruda against a standard platinum-containing chemotherapy regimen. Data presented at the ESMO congress last year demonstrated that the ADC plus PD-1 inhibitor combination resulted in a median overall survival of 31.5 months, significantly higher than the 16.1 months achieved with chemotherapy. This combination therapy reduced the risk of death by 53%. Additionally, the dual regimen achieved a median progression-free survival of 12.5 months, compared to 6.3 months for chemotherapy, thereby lowering the risk of disease progression or death by 55%.

The combination of Padcev and Keytruda was initially granted clearance under the FDA’s accelerated approval pathway in April of the previous year. This approval was later converted to full approval in December. In the United States, Astellas co-markets Padcev with Pfizer, who acquired the Nectin-4-targeted ADC through its $43-billion acquisition of Seagen.

Earlier this year, Astellas revised its peak annual sales forecast for Padcev, increasing it to as much as JPY 500 billion (approximately $3.5 billion), up from the previous estimate of JPY 400 billion (about $2.8 billion).

This development marks a significant shift in the treatment landscape for bladder cancer, offering new hope for patients with limited options. The combination of Padcev and Keytruda represents a significant advancement in oncology, particularly for those who are not candidates for traditional platinum-based chemotherapy, providing an alternative that shows marked improvements in survival and disease progression metrics.