What Is Inlexzo, and Why Does It Matter?
Inlexzo is a new treatment for a type of bladder cancer in adults that hasn’t spread to the muscles and doesn’t respond to Bacillus Calmette-Guérin (BCG) therapy. It’s approved for treating non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ that may or may not have small growths (papillary tumors).
Health care providers often recommend radical cystectomy (surgical removal of the bladder) in patients who don’t get help from BCG therapy. But it is a major surgery with serious side effects that can affect quality of life and carries a risk for death after surgery. As NMIBC mainly affects older adults, many may not be fit or willing to have their bladder removed.
What makes Inlexzo unique is how it delivers the medicine. It uses a small device that slowly releases gemcitabine, a cancer-fighting drug, directly into your bladder over time (extended release). Gemcitabine works by stopping cancer cells from making new DNA, preventing their growth and spread. The device stays inside the bladder for three weeks, giving the medicine more time to work where it’s needed most.
Although gemcitabine has been given directly into the bladder for many years, this is the first and only system approved to deliver a bladder cancer drug in this way and may offer a new option for people who can’t have or choose not to have their bladder removed.
Why Was It Approved?
Inlexzo was approved because it showed promising and long-lasting results in studies involving adults with NMIBC that didn’t get help from BCG treatment.
In a study, 82% of people who had received Inlexzo every three weeks for six months, followed by once every month for up to 18 months, showed a complete response, meaning no signs of cancer were found during follow-up tests. About half (51%) of those who saw a response stayed cancer-free for at least a year. Most people in the study were older adults, including many who were 65 or older.
However, this treatment isn’t suitable for everyone as a small number of people developed more serious cancer after delaying their bladder removal surgery.
The most common side effects reported in the study were urinary problems, such as feeling a strong urge to urinate or needing to urinate often, pain while urinating, urinary tract infections, blood in urine, and bladder irritation. Some blood test results changed, such as levels of certain blood cells and substances in the blood, like hemoglobin, sodium, potassium, and liver enzymes, were also common. About 1 in 4 people had serious side effects, and a few had to stop treatment early.
What Do I Need to Know?
Inlexzo is placed into your bladder by a health care provider using a special tube called a catheter. The device stays in your bladder for three weeks and is then removed by your health care provider. You’ll get a new replacement every three weeks for up to six months. After that, you may continue treatment once every 12 weeks for up to 18 months. Inlexzo is inserted in an outpatient setting, without general anesthesia or the need for immediate monitoring.
Your health care provider may give you antibiotics before inserting or removing Inlexzo. Before the procedure, don’t empty your bladder. During treatment, drink plenty of fluids daily to help your body make enough urine for the drug to work properly in the bladder. After it is inserted, you can urinate as usual. While the device is in the bladder and for one day after it’s removed, you should avoid letting urine touch your skin.
Inlexzo isn’t recommended for everyone. You shouldn’t use it if you have a hole in your bladder or if you’re allergic to gemcitabine, the medicine it contains. Let your health care provider know about all the prescription and over-the-counter medicines you take, including vitamins and supplements.
If you’re pregnant or could become pregnant, talk to your health care provider. Inlexzo may harm a fetus, so you’ll need to use birth control during treatment and for six months after your last dose. Men with partners who could get pregnant should use birth control during treatment and for three months afterward. It is important to inform your health care provider that you have Inlexzo before getting an MRI scan.
It is not known if Inlexzo enters breast milk. Do not breastfeed during treatment and for one week after final removal.