EC Approves Astellas' PADCEV for Urothelial Cancer

The European Commission (EC) has granted approval for Astellas Pharma's PADCEV (enfortumab vedotin) in combination with KEYTRUDA (pembrolizumab) as a first-line treatment for advanced urothelial cancer. This combination therapy is specifically targeted at adults who have unresectable or metastatic urothelial cancer and are eligible for platinum-containing chemotherapy.

PADCEV functions as an antibody-drug conjugate, whereas KEYTRUDA acts as a PD-1 inhibitor. The marketing authorisation covers all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.

The EC's decision is based on data from the Phase III EV-302 clinical trial (KEYNOTE-A39). This trial revealed that the combination of enfortumab vedotin and pembrolizumab nearly doubled the median overall survival (OS) for patients. The trial showed that patients receiving the combination therapy had a median OS of 31.5 months, compared to 16.1 months for those receiving standard platinum-containing chemotherapy. This represents a 53% reduction in the risk of death.

Additionally, the combination therapy significantly extended progression-free survival (PFS). Patients treated with enfortumab vedotin and pembrolizumab experienced a median PFS of 12.5 months, whereas those treated with chemotherapy had a median PFS of 6.3 months. This equates to a 55% reduction in the risk of cancer progression or death.

Astellas Pharma is now working with local regulatory authorities and health technology assessment bodies across the EU to ensure patient access to this newly approved treatment combination. Ahsan Arozullah, Astellas' head of oncology development and senior vice-president, expressed the company's enthusiasm regarding the approval. He highlighted that the approval aligns with recent updates to European clinical guidelines and marks a significant milestone in their collaboration with clinical trial investigators, study participants, their families, and the broader bladder cancer community.

Arozullah stated, "We are delighted that the European Commission has approved enfortumab vedotin in combination with pembrolizumab as first-line treatment for patients with unresectable or metastatic urothelial cancer. This approval is testament to our ongoing partnership with clinical trial investigators, study participants and their families, and the broader bladder cancer community. We look forward to patients across the European Union gaining benefit from this combination early in their treatment journey."

In addition to the EU approval, Astellas Pharma recently received approval from the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA) for PADCEV to treat locally advanced or metastatic urothelial cancer. This series of approvals underscores the global recognition of PADCEV's potential to significantly improve outcomes for patients with advanced urothelial cancer.

The combination of PADCEV and KEYTRUDA offers a new therapeutic option that enhances survival rates and delays disease progression, providing new hope for patients battling this aggressive form of cancer. With these approvals, Astellas Pharma is poised to make a substantial impact on urothelial cancer treatment across multiple regions, ensuring that more patients can access these potentially life-extending therapies.