FDA Approves New Option for Certain People with Advanced Bladder Cancer
April 17th, 2017
On April 17, the FDA granted accelerated approval to TECENTRIQ® (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. TECENTRIQ was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). It is not known if TECENTRIQ is safe and effective in children.
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
- First and only cancer immunotherapy approved as initial treatment for people with advanced bladder cancer not eligible to receive cisplatin chemotherapy
- Up to half of all people with advanced bladder cancer are unable to receive cisplatin chemotherapy as an initial treatment
- 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
Important Safety Information
What is the most important information about TECENTRIQ?
TECENTRIQ can cause your immune system to attack normal organs and tissues 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 of pneumonitis 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 or mucus in your stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
- Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–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
- Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
- Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
- Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of your face or lips, dizziness, fever, feeling like passing out, and back or neck pain
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 of 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. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with TECENTRIQ. Females who are able to become pregnant:
- your healthcare provider should do a pregnancy test before you start treatment with TECENTRIQ
- 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 when used alone include:
- feeling tired
- shortness of breath
- decreased appetite
The most common side effects of TECENTRIQ when used in lung cancer with other anti-cancer medicines include:
- feeling tired or weak
- hair loss
- decreased appetite
The most common side effects of TECENTRIQ when used with paclitaxel protein-bound include:
- hair loss
- tingling or numbness in hands or feet
- feeling tired
- low red blood cells (anemia)
- low white blood cells
- decreased appetite
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 [accompanying] full Prescribing Information for additional Important Safety Information.
“We are pleased that TECENTRIQ will now be available to more people with advanced bladder cancer, including those who are unable to receive initial treatment with cisplatin chemotherapy. TECENTRIQ was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose cancer progressed after receiving other medicines, either before surgery or after surgery, or after their disease has spread.”