New Approval Means More Bladder Cancer Patients Can Access Powerful Immunotherapy Combination: What To Know About Keytruda + Padcev

“It completely changes the standard of care for this aggressive disease,” explains Dr. Peter O’Donnell, a medical oncologist at UChicago Medicine.

What’s Different About This Approval

Until now, this combination was mainly for patients who couldn’t receive cisplatin, a common chemotherapy drug. The new approval means any patient preparing for bladder‑removal surgery can be considered for this treatment — even those who are eligible for cisplatin.

Dr. David Aggen, an assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City, calls it “a platinum‑free option before and after surgery,” offering patients more flexibility and fewer side effects than traditional chemotherapy.

Many people with bladder cancer can’t safely take cisplatin chemo because of kidney problems, hearing loss, or other health issues. This new regimen gives those patients access to an effective systemic treatment that’s generally well tolerated.

In a large clinical trial (KEYNOTE‑B15/EV‑304), patients who received the Keytruda‑Padcev combination had better outcomes than those treated with standard chemotherapy.

Dr. Aggen notes that more patients achieved a pathologic complete response, fewer experienced recurrence, and overall survival improved.

What Patients Should Know

This treatment avoids some of cisplatin’s toughest side effects — such as kidney damage and hearing loss — but it can cause others, including skin reactions, nerve tingling, or high blood sugar. Doctors can usually monitor and manage these issues.

“It delivers significantly more efficacy without additional — and perhaps even less — toxicity than the previous standard,” says Dr. Jeffrey Holzbeierlein of the University of Kansas Cancer Center.

For most patients in the U.S. with muscle‑invasive bladder cancer, the recommended approach is now Keytruda plus Padcev (P+EV) before surgery, followed by cystectomy.

Researchers are still studying whether some patients who respond exceptionally well might one day delay or even avoid surgery, but that’s still being studied.

As Dr. Aggen summarizes, this combination has transformed treatment for muscle‑invasive bladder cancer, offering new hope and better outcomes for patients facing this challenging disease.

RELATED: Diagnosing Muscle-Invasive Bladder Cancer: The Initial Work-Up

What to Expect from Bladder Cancer Surgery

When bladder cancer is diagnosed, surgery may be recommended to remove the bladder and surrounding cancerous tissue to prevent the disease from spreading. Your treatment path will depend on several factors, including your overall health, the stage and grade of your cancer, and your personal preferences.

While patient preference is central to treatment planning, doctors also evaluate several clinical factors that may determine whether surgery or bladder-preserving therapy is more appropriate.

These include:

• Age and overall physical fitness
• Other medical conditions (co-morbidities)
• Prior radiation treatments to the pelvis

“There are patients who would be at very high risk for adverse surgical outcomes based on potentially factors such as their level of activity, their age, their other medical comorbidities,” Dr. Elizabeth Wulff, of the University of Kansas Medical Center, explained to SurvivorNet.

WATCH: The Challenge Of Treating A Many-Layered Organ

Bladder cancer surgery typically involves removing the bladder (a procedure called cystectomy) and nearby tissue. In many cases, a urinary diversion is also needed. This reroutes the flow of urine through a new pathway.

There are two main surgical approaches:

• Open Surgery: This traditional method involves a single, large incision from the belly button downward. The surgeon uses their hands to access and remove the bladder directly.
• Robotic-Assisted Laparoscopic Surgery: This is a minimally invasive technique using several small incisions. The surgeon operates robotic instruments to perform the procedure with precision.

Bladder Cancer Symptoms & Risk Factors

Your bladder is a hollow, muscular, balloon-shaped organ that expands as it fills with urine, an essential component of your body’s urinary system.

Bladder cancer begins when the cells lining the inside of the bladder start growing uncontrollably and form tumors.

Common symptoms of bladder cancer may include:

• Frequent urination
• Pain or burning during urination
• Flank pain (discomfort in the sides of the lower back)
• A sudden, urgent need to urinate
• Blood in the urine, which may appear pink, red, or cola-colored

Smoking is one of the most dangerous contributors to bladder cancer. In fact, the National Institutes of Health reports that roughly half of all bladder cancer cases are caused by smoking.

The toxic chemicals in nicotine and other compounds found in cigarettes remain in the bladder for extended periods before being flushed out through urine — giving them more time to damage bladder tissue.

WATCH: Understanding bladder cancer risk factors.

Tobacco smoke is a toxic mix — the Centers for Disease Control and Prevention (CDC) says that it contains over 7,000 chemicals, with at least 70 known to cause cancer.

While most often linked to lung cancer, smoking is also a major driver of other cancers, including bladder cancer.

Questions To Ask Your Doctor

• Should I consider a treatment combination like pembrolizumab (Keytruda) + enfortumab vedotin‑ejfv (Padcev)?
• What immunotherapy side effects should I be aware of?
• How and when is “perioperative” treatment given?
• What treatment schedule should I expect after surgery?

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