Bladder cancer is one of the most common cancers worldwide, with more than 600,000 new cases each year and most patients diagnosed with NMIBC, an early stage of bladder cancer. High-risk patients often need repeated treatments and surgeries, and some may eventually require bladder removal surgery (cystectomy) if the cancer returns or stops responding to BCG therapy, emphasizing the need for better treatment options.
Imfinzi is a lab-made monoclonal antibody that works by blocking the protein called PD-L1, which is used by some cancer cells to evade your immune system. By stopping PD-L1 from attaching to PD-1 or CD80 proteins on immune cells, Imfinzi helps your immune system recognize and attack cancer cells without triggering cell death via antibody‑dependent mechanisms.
First approved in 2017, Imfinzi is used to treat certain types of lung, bladder, liver, bile duct, and uterine cancers, including settings where surgery is part of the treatment plan. This approval matters as this marks the first FDA-approved immunotherapy plus BCG combination that offers a new therapeutic option for patients with BCG-naive, high-risk NMIBC in the early curative‑intent setting.
Why Was It Approved?
The FDA approval was supported by data from a clinical trial, which included 1,018 patients with high-risk NMIBC who had already undergone tumor removal surgery. Patients were randomly assigned to receive Imfinzi (once every four weeks for up to 13 cycles) along with BCG therapy, BCG therapy alone, or another experimental treatment for up to 1 year. The results showed that patients who received Imfinzi plus BCG therapy had a 32% lower risk of the cancer returning, persisting, worsening, or leading to death compared with those who received BCG therapy alone. After more than five years of follow-up, patients who received the Imfinzi plus BCG combination regimen showed early and long-lasting benefits, with improvements seen in less than four months after starting the treatment. At the time of analysis, more than half of patients in both groups were still alive without disease progression, so the median disease-free survival had not been reached.
Imfinzi may cause the immune system to attack healthy organs including the liver, lungs, kidneys, intestines, hormonal glands, pancreas, and skin, leading to serious and even life‑threatening complications during or after treatment.
What Do I Need to Know?
You receive Imfinzi as a 60‑minute intravenous infusion. The dose and schedule depend on your cancer, weight, and treatment plan. For BCG‑naive patients with high‑risk NMIBC, the FDA‑recommended dose is 1,500 milligrams every four weeks for up to 13 cycles in combination with BCG or until the cancer returns or worsens or side effects require stopping.
Your health care provider will do certain blood tests to check your liver and kidney function and thyroid levels before and during treatment. Your health care provider will also observe you for immune-related side effects and may pause or stop Imfinzi based on the type and severity of the reaction.
Before receiving Imfinzi, tell your health care provider about your medical history, especially if you have any immune system diseases (such as Crohn’s disease, ulcerative colitis, or lupus), if you have had or plan to have an organ transplant (including corneal graft) or have received a donor stem cell transplant or chest radiation, or if you have any nervous system conditions such as myasthenia gravis or Guillain-Barré syndrome. Also tell your health care team about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Imfinzi may also cause reactions, such as chills or shaking, itching or rashes, dizziness, or difficulty breathing, during infusion. Call your health care provider right away if you have a new or worse cough, shortness of breath, severe diarrhea, unusual bleeding or bruising, unusual headaches, extreme tiredness, severe muscle pain or weakness, or painful sores (in the mouth or nose, throat, or private parts); notice yellowing of your skin or eyes, eye pain, sensitivity to light, vision problems, or rash, blistering, or peeling of the skin; or experience changes in mood or behavior (such as irritability, confusion, or forgetfulness) or increased hunger or thirst.
