Understanding the FDA Imfinzi Combo Approval for Bladder Cancer Care

Adjuvant treatment with Imfinzi (durvalumab) plus chemotherapy, followed by single-agent, adjuvant Imfinzi following radical cystectomy received U.S. Food and Drug Administration (FDA) approval for muscle invasive bladder cancer in March of 2025, marking a milestone in treatment, according to Dr. Matthew Galsky.

In an interview with CURE, Galsky — who serves as a professor of Medicine (Hematology and Medical Oncology) at The Tisch Cancer Institute, part of the Mount Sinai Health System, in New York — discussed what makes this approval significant for patients and providers managing muscle-invasive bladder cancer. He goes on to share that data from the randomized, open-label, multicenter, phase 3 NIAGARA trial evaluated the now-FDA-approved approach, which demonstrated a statistically significant improvement in event-free survival and overall survival.

Galsky is also the director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, and associate director for Translational Research, at The Tisch Cancer Institute. Read more on his key takeaways for patients regarding the FDA approval here.

Transcript:

A standard treatment for muscle-invasive bladder cancer is the surgical removal of the bladder. We know that after the bladder is removed, a subset of individuals will experience the cancer reappearing elsewhere in the body, developing metastatic recurrence, typically months to years later.

For decades, doctors attempted to combine chemotherapy with surgery to eradicate any microscopic cancer cells that might be present, aiming to reduce the risk of metastatic recurrence. When chemotherapy is administered before surgery, it's called neoadjuvant therapy. This concept of giving chemotherapy prior to surgery to treat potential microscopic spread of cancer is used in various solid tumors. When chemotherapy is given after surgery, it's known as adjuvant therapy.

For decades, the only neoadjuvant therapy proved beneficial in muscle-invasive bladder cancer was a combination of chemotherapy drugs, including cisplatin. This truly represented the standard treatment approach for many years because nothing had been shown to be superior.

Finally, after several decades, the NIAGARA trial demonstrated that integrating immunotherapy in the pre-surgical and post-surgical periods decreases the risk of metastatic disease development and improves longevity for patients.

Transcript has been edited for clarity and conciseness.

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