Daniele Paone, Vice President, US Commercial Oncology, DNA Damage Response Franchise at AstraZeneca, shared on LinkedIn:
“This content is for US audiences only:
Today, AstraZeneca announced FDA approval of our perioperative immunotherapy combination for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin-based chemotherapy. Positive high-level results from the VOLGA Phase III study shared recently at the ESMO led to the FDA’s decision, with data showing a 42% reduction in the risk of death and a manageable safety profile.
Patients with MIBC who are not able to receive cisplatin-based chemotherapy have few treatment options and poor prognosis. Our team is committed to transforming outcomes for this patient population and today’s announcement marks a new era in innovative bladder cancer care.
The VOLGA regimen is AstraZeneca’s third approval in bladder cancer in less than two years, building on our momentum with POTOMAC and NIAGARA. We’re proud of this progress and remain focused on advancing care for people with bladder cancer.
You can also read: FDA Approves Durvalumab Plus Enfortumab Vedotin for Muscle-Invasive Bladder Cancer
