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FDA Approval: Atezolizumab (Tecentriq) for Bladder Cancer
FDA approved Atezolizumab (Tecentriq), an anti-PD-L1 checkpoint inhibitor, for certain people with bladder cancer. What was approved, the evidence, and what it does and doesn't mean.
Original commentary from the Cancer Explained editorial team.
Please note: this page is educational only — it is not medical advice, and it does not speculate about anyone’s health beyond reliable public reporting. For questions about your own health, talk with your healthcare team.
The approval, and what happened to it
On May 18, 2016 the FDA gave accelerated approval to atezolizumab, sold as Tecentriq, under BLA 761034. The approval letter is exact about who it covered. It was for people with locally advanced or metastatic urothelial carcinoma whose disease had grown during or after platinum chemotherapy. It also covered growth within 12 months of platinum given before or after surgery.
Urothelial carcinoma is the most common type of bladder cancer. NCI called this the first new bladder cancer treatment in two decades. It was also the first PD-L1 blocker the FDA had cleared for any cancer.
That approval no longer exists. The FDA keeps a register of withdrawn cancer accelerated approvals. It lists this one with an approval date of 5/18/2016 and a withdrawal date of 4/13/2021. A second bladder use, approved 4/17/2017 for people who could not have cisplatin, was withdrawn on 12/2/2022.
The current Tecentriq label carries no bladder cancer use at all. It lists lung cancer, liver cancer, melanoma, and alveolar soft part sarcoma.
How the drug works
PD-L1 is a protein some tumor cells carry on their surface. It binds to PD-1 on immune cells. That pairing acts as a brake on the immune response.
Atezolizumab blocks PD-L1 so the pairing cannot happen. NCI describes this as releasing the brakes, letting immune cells attack the tumor. Drugs that do this are called checkpoint inhibitors. Our page on checkpoint inhibitors explains the class.
The evidence behind the 2016 decision
The approval rested on a single-arm study of 310 people with locally advanced or metastatic urothelial carcinoma that had worsened during or after platinum chemotherapy. Everyone in the study got the drug. There was no comparison group.
About 15% had at least partial shrinkage of their tumors. Those responses lasted from 2.1 months to more than 13.8 months.
PD-L1 levels tracked with response. Among people whose tumors tested positive, 26% responded. Among those testing negative, 9.5% did. The FDA cleared a companion test, Ventana PD-L1 (SP142), on the same day. NCI quoted Dr. Andrea Apolo warning that the test was not required, and that people with negative tumors might still respond.
The most common side effects were fatigue, loss of appetite, nausea, urinary tract infection, fever, and constipation. The drug can also cause infection and serious immune-related side effects. Our page on immunotherapy side effects covers what to watch for.
Why a shrinkage rate was not the end of the story
Accelerated approval lets a drug reach patients on an early signal — here, tumor shrinkage — in exchange for a promise. The company must then run a confirmatory trial showing the drug helps people live longer or better.
That is the step that failed. NCI records that Roche withdrew the bladder use in the United States, announcing it on March 8, 2021. The required confirmatory trial had not met its main endpoint of improved overall survival. AstraZeneca had pulled durvalumab, another PD-L1 blocker, from the same setting shortly before.
Tumors shrinking is not the same as people living longer. A single-arm study of 310 people cannot separate the drug's effect from the course of the disease, or from who happened to enroll. That is what the confirmatory trial was there to test. The answer came back negative.
What is used for advanced bladder cancer now
NCI's health-professional summary lists enfortumab vedotin plus pembrolizumab as a first-line option for stage IV bladder cancer, for people with no reason to avoid it. Enfortumab vedotin is an antibody-drug conjugate. An antibody finds a protein called nectin-4 and carries in a drug that stops cells dividing. Pembrolizumab blocks PD-1 rather than PD-L1.
Other listed options include chemotherapy with immunotherapy, chemotherapy alone, radiation, and surgery for symptom relief. Our page on bladder cancer treatment by stage sets out the sequence.
When to get checked
NCI states that bladder cancer typically shows up as blood in the urine, either visible or found on a test. See a clinician promptly for:
- Any visible blood in the urine, even once, even painless, at any age
- Blood found on a routine urine test
- Needing to pass urine much more often, including waking at night
- Pain or burning when passing urine, with no infection found
- One-sided flank pain that persists
Visible blood in the urine always needs assessment. NCI notes that CT and ultrasound are not sensitive enough to rule bladder cancer out, and that cystoscopy — looking inside the bladder with a thin camera — is the most useful test.
What this does not mean
- This 2016 approval was withdrawn on April 13, 2021. Nothing on this page describes a treatment currently available for bladder cancer in the United States.
- Atezolizumab itself is still approved, for other cancers. The withdrawal was specific to bladder cancer.
- An accelerated approval is a conditional bet on an early signal, not a finding that a drug helps people live longer.
- A 15% response rate in a single-arm study describes tumors on scans in one group of patients. It is not a survival figure.
- PD-L1 test results shift the odds of response. They do not decide who can or cannot be treated.
Sources
- FDA approval letter, BLA 761034, Tecentriq (atezolizumab), May 18, 2016 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/761034Orig1s000ltr.pdf
- FDA, Withdrawn: Cancer Accelerated Approvals — https://www.fda.gov/drugs/resources-information-approved-drugs/withdrawn-cancer-accelerated-approvals
- FDA Drugs@FDA overview, BLA 761034 (TECENTRIQ) — https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761034
- FDA, TECENTRIQ prescribing information, May 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761034s062lbl.pdf
- NCI Cancer Currents, FDA Approves New Immunotherapy Drug for Bladder Cancer (June 7, 2016, updated March 2021) — https://www.cancer.gov/news-events/cancer-currents-blog/2016/fda-atezolizumab-bladder
- NCI PDQ, Bladder Cancer Treatment (Health Professional Version) — https://www.cancer.gov/types/bladder/hp/bladder-treatment-pdq
How this article was prepared
An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.
The National Cancer Information Foundation publishes Cancer Explained. This page is for learning. It is not medical advice and does not suggest a test or treatment.
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Put the story in context
Prevention, possible warning signs, screening, and diagnosis
This story relates to Bladder cancer. The information below is general: it does not reveal anything else about a public person’s health, and not every point applies to every cancer. Personal advice depends on age, symptoms, family history, exposures, and medical history.
Prevention and risk reduction
Not every cancer can be prevented. Avoiding tobacco, protecting skin from ultraviolet radiation, limiting alcohol, staying active, and receiving recommended HPV or hepatitis B vaccination can lower the risk of certain cancers. A risk factor is not a prediction or a cause in one individual.
Symptoms and possible early signs
Possible signs vary and are often caused by conditions other than cancer. Changes worth discussing include a new lump, unexplained bleeding or weight loss, a persistent cough, lasting bowel or bladder changes, a changing skin spot, or symptoms that persist or worsen. Some early cancers cause no symptoms.
Screening and early detection
Screening looks for certain cancers before symptoms begin. Recommended tests exist only for some cancers and depend on age and risk. Screening can have benefits and harms; it is not the same as evaluating a new symptom, and there is no single routine scan or blood test that reliably screens for every cancer.
How cancer is diagnosed
Diagnosis may involve a history and exam, imaging, laboratory tests, and often a biopsy. Pathology can identify the cancer type and may test biomarkers that guide treatment. Symptoms, screening results, tumor markers, or online stories alone cannot confirm cancer.
Learn about this story’s cancer topic
A public story may encourage questions, but it should not be used to estimate your risk or choose testing. Contact a healthcare professional about a persistent or concerning change. Seek urgent care for severe or rapidly worsening symptoms.