Breaking News: European Commission Gives Green Light to Astellas’ PADCEV and Keytruda Combo for Advanced Urothelial Cancer Treatment!
Description:
First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years. European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial. TOKYO , Aug. 28, 2024 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the European Commission has granted Marketing Authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy. The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.
How this will affect me:
With the approval of PADCEV and Keytruda combo for advanced urothelial cancer treatment, eligible patients will have access to a more effective treatment option that has shown superior results in clinical trials. This means improved chances of survival and better outcomes for those battling this type of cancer. Patients who are eligible for platinum-containing chemotherapy can now consider this new regimen under the guidance of their healthcare providers.
How this will affect the world:
The approval of this new treatment combination by the European Commission marks a significant advancement in the field of oncology. It sets a new standard for the first-line treatment of urothelial cancer and may pave the way for similar innovative approaches in the treatment of other types of cancer. The results of the Phase 3 EV-302 trial demonstrate the potential for improved outcomes and survival rates for patients globally, leading to a positive impact on the world of cancer care.
Conclusion:
In conclusion, the approval of PADCEV and Keytruda combo by the European Commission for advanced urothelial cancer treatment represents a major milestone in the fight against cancer. This decision not only benefits individual patients by offering a more effective treatment option, but also contributes to the broader landscape of cancer research and treatment worldwide. The pioneering approach of combining enfortumab vedotin with pembrolizumab showcases the potential for groundbreaking advancements in cancer therapy, bringing hope and progress to patients and healthcare providers alike.
