New Drug Combination Approved for Advanced Bladder Cancer
Padcev (enfortumab vedotin-ejfv) when used with Keytruda (pembrolizumab) can now be used to treat advanced bladder cancer. The U.S. Food and Drug Administration (FDA) announced this news in February 2020. This drug combination was designated as a breakthrough therapy.1,2
What is a breakthrough therapy?
Breakthrough therapies are treatments that show early promise in providing much better results compared to currently available drugs. Breakthrough therapies focus on treating serious or life-threatening conditions.3
Who can receive this treatment?
The combination of Padcev and Keytruda was approved for use in people with inoperable (meaning surgery is not recommended), advanced bladder cancer who cannot take cisplatin-based chemotherapy.2 Padcev and Keytruda are given by intravenous injection (IV).
Why is this new treatment exciting for the bladder cancer community?
The Padcev/Keytruda combination shows impressive results in helping people with bladder cancer, with 90 percent achieving disease control. The effectiveness of a cancer treatment is measured by the “response rate,” which is the percentage of patients whose cancer shrinks or disappears after treatment.
As of February 20, 2019, response rates were:2
- Overall response rate (62 percent)
- Complete response rate (14 percent)
In addition, the Padcev/Keytruda combination seems to be safe and well-tolerated.2
The clinical study for Padcev + Keytrudra
The Padcev/Keytruda combination have moved on to a Phase 2 clinical trial. This means it is in the early stages of being tested on humans. As of February 2020, 407 people are enrolled in this clinical trial. The trial is recruiting new patients.
What are the side effects of Padcev + Keytruda?
The most common side effects of using the drug combination were:
- Fatigue (66 percent)
- Decreased appetite (52 percent)
- Peripheral neuropathy (52 percent)
- Hair loss (45 percent)
- Rash (45 percent)
- Diarrhea (41 percent)
- Increased immune system activity (17 percent)
However, fewer than 1 in 10 people stopped taking Padcev/Keytruda due to treatment side effects.
Things to know about Padcev/Keytruda
People were excluded from the Padcev/Keytruda trial if they already had:2
- More advanced neuropathy
- Nervous system tumors
- Conditions that required them to take high doses of steroids
Padcev is approved by the FDA to be used alone to treat some people with locally advanced or metatastic bladder.2
Keytruda is also approved to be used alone for people with BCG-unresponsive, high-risk, non-muscle invasive bladder cancer and some people with advanced or metastatic bladder cancer.