FDA Approves New Immunotherapy Medicine for Specific Type of Advanced Bladder Cancer

May 18th, 2016

On May 18, the FDA granted accelerated approval to TECENTRIQ™ (atezolizumab) for treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

The indication for TECENTRIQ is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.


News in brief

  • Accelerated approval allows conditional approval of a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit
  • TECENTRIQ is the first and only anti-PDL1 cancer immunotherapy approved by the FDA
  • TECENTRIQ is the first FDA-approved treatment for people with a specific type of bladder cancer in more than 30 years
  • Urothelial carcinoma is a type of bladder cancer that accounts for approximately 90 percent of the disease and can also be found in the renal pelvis, ureter and urethra

Supporting Information

Important Safety Information

What is the most important information about TECENTRIQ?

TECENTRIQ can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.

Call or see your healthcare provider right away if you get any symptoms of the following problems or these symptoms get worse.

TECENTRIQ can cause serious side effects, including:

  • Lung problems (pneumonitis)–signs and symptoms may include new or worsening cough, shortness of breath, and chest pain
  • Liver problems (hepatitis)–signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
  • Intestinal problems (colitis)–signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
  • Hormone gland problems (especially the pituitary, thyroid, adrenal glands, and pancreas)–signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, your voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
  • Nervous system problems (neuropathy, meningitis, encephalitis)–signs and symptoms of nervous system problems may include severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, and neck stiffness
  • Inflammation of the eyes–signs and symptoms may include blurry vision, double vision, or other vision problems, eye pain or redness
  • Severe infections–signs and symptoms of infection may include fever, cough, frequent urination, flu-like symptoms, and pain when urinating
  • Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and swelling of your face or lips

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with TECENTRIQ if you have severe side effects.

Before you receive TECENTRIQ, tell your healthcare provider about all your medical conditions, including if you:

  • Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects your nervous system (such as myasthenia gravis, or Guillain-Barre syndrome); or are being treated for an infection
  • Are pregnant or plan to become pregnant. TECENTRIQ can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 5 months after the last dose of TECENTRIQ
  • Are breastfeeding or plan to breastfeed. It is not known if TECENTRIQ passes into your breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of TECENTRIQ in people with urothelial carcinoma include:

  • feeling tired
  • decreased appetite
  • nausea
  • constipation
  • urinary tract infection
  • diarrhea
  • fever

The most common side effects of TECENTRIQ in people with non-small cell lung cancer include:

  • feeling tired
  • decreased appetite
  • shortness of breath
  • cough
  • nausea
  • muscle or bone pain
  • constipation

TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of TECENTRIQ. Ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.


Sandra Horning, M.D.

“TECENTRIQ is a new medicine that can help work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy. We thank the scientists, doctors, patients and their families who made it possible to bring TECENTRIQ to people with advanced urothelial carcinoma.”