This new approval helps more people. Before this choice was available, this combination of medicines was only for patients who could not take a common chemotherapy drug called cisplatin. Now, any adult with this type of bladder cancer who can have surgery can get this treatment.
Keytruda and Keytruda Qlex are immunotherapies that work by helping your body fight cancer. They help your immune system find and destroy cancer cells. Padcev is a different type of targeted drug given along with them to attack and kill cancer cells directly. When doctors use this combination of medicines together before and after surgery, it helps lower the chance that the cancer will come back.
Why Was It Approved?
The FDA approved this treatment based on a clinical study with 808 patients. All of the patients had bladder cancer that had not been treated yet. They were all candidates to have surgery to remove their bladder. One group of patients received this combination therapy (Keytruda or Keytruda Qlex given with Padcev) before and after their surgery. The other group received standard chemotherapy before their surgery. Standard chemotherapy is the traditional mix of strong cancer drugs, called gemcitabine and cisplatin, that doctors have used for many years.
The study looked at event-free survival. This is the amount of time patients live without the cancer returning or getting worse. The patients who received the new combination stayed free of cancer signs for a longer period of time. The median time without the cancer returning or getting worse was 48.5 months for the standard chemotherapy group. For the patients who got the Keytruda and Padcev combination, that median time was not reached. This means that more than half of the patients on the combination therapy were still alive without their cancer getting worse at the time of the analysis.
The study also tracked how many patients stayed alive overall. The median overall survival time was not reached in either group because most patients were still alive at the time of the analysis. The overall safety results and side effects were similar to what doctors have seen in other studies of these drugs.
What Do I Need to Know?
How you get this treatment depends on which medicine your doctor chooses for your combination. Keytruda is given as an infusion into your vein. Keytruda Qlex is given as a shot under the skin of your thigh or stomach. Padcev is always given as an infusion into a vein. You will get these treatments before your bladder surgery and then continue them for a set time after your surgery is complete.
Like all cancer treatments, this combination can cause side effects. The most common side effects include skin rashes, itching, hair loss, and dry eyes. Patients may also feel very tired, lose weight, or have a smaller appetite. Other common problems include diarrhea, nausea, constipation, changes in how things taste, and urinary tract infections.
These medicines can cause numbness, tingling, or pain in your hands or feet. This is called peripheral neuropathy. They can also cause high blood sugar levels or body swelling. Let your health care team know right away if you get any skin changes, a new cough, or trouble breathing. Your doctor can monitor your blood and help you manage these side effects.
These treatments can cause severe harm to a fetus. Women who can get pregnant must take a pregnancy test before starting treatment. They must use reliable birth control during treatment and for four months after their final dose. Women should not breastfeed during treatment and for four months after the last dose. Talk to your doctor about all other medicines you take to avoid bad drug interactions.
