(BPT) – Betsy knows things aren’t always what they seem. But, two years ago when she showed up in the emergency room with severe pain in her side, she was quite sure she was experiencing kidney stones.
A few weeks later, however, Betsy learned she had something much more serious — advanced bladder cancer.
According to the American Cancer Society, bladder cancer is the sixth most common cancer in the U.S., and about 79,000 people will be diagnosed with the disease this year.1 About 11 percent of those will be diagnosed with advanced bladder cancer, meaning the disease has spread beyond the bladder to other organs.2
“Typically, bladder cancer can be caught early, as it often causes noticeable symptoms, like blood in the urine or other symptoms, such as having to urinate more often than usual, pain or burning during urination, or feeling as if you need to go immediately,” said Michael Harrison, M.D., assistant professor of medicine at Duke University School of Medicine. “However, some people don’t have symptoms until the cancer has advanced. Those symptoms can include lower back pain, loss of appetite and weight loss, swelling in the feet and bone pain.”
When diagnosed with advanced bladder cancer, many people are treated with a type of chemotherapy called cisplatin. However, based on her physician’s assessment, her doctor thought cisplatin might be too difficult for Betsy’s body to handle. Her doctor suggested she may be a good candidate for a clinical trial for a cancer immunotherapy.
The body’s immune system is designed to detect and protect the body against cells that are perceived by the body as foreign or abnormal. It can even recognize normal cells that have become cancerous, and can eliminate those abnormal cells from the body. But cancer can evolve and often finds ways to camouflage itself from the immune system. Cancer immunotherapy is designed to work with the body’s own immune system. It can also affect normal cells.3
Betsy entered a clinical trial for the cancer immunotherapy TECENTRIQ® (atezolizumab). While not everyone responds to treatment, Betsy began seeing some of the cancer in her bladder begin to shrink. “My oncologist said ‘Well, this is looking good,’” said Betsy.
TECENTRIQ is approved 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).3
It’s important to remember that every patient is different, so they should speak with their doctor about treatment options and side effects. 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.
“Thanks in part to people like Betsy who participate in clinical trials, the FDA had the data it needed to assess this anti-PDL1 cancer immunotherapy for approval,” said Dr. Harrison. “This approval is important because many people with this type of cancer may not be able to take a cisplatin-based chemotherapy, and there has been a need for other options.”4
“Thank you, thank you, thank you,” said Betsy. “I just thank the scientists, the chemists, the lab workers, everybody that was involved.”
For more information about bladder cancer, talk with your doctor or visit the Bladder Cancer Advocacy Network’s website at www.bcan.org, or the American Cancer Society’s website at www.cancer.org.
Indication and Safety Information
TECENTRIQ is a prescription medicine used to treat:
a type of bladder and urinary tract cancer called urothelial carcinoma.
TECENTRIQ may be used when your bladder cancer:
- has spread or cannot be removed by surgery (advanced urothelial carcinoma), and
- you are not able to take chemotherapy that contains a medicine called cisplatin, or
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children. The approval of TECENTRIQ in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
Important Safety Information
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.
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with TECENTRIQ if a patient has severe side effects.
Patients should call or see their healthcare provider right away if they 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, or chest pain
- Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, 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 the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
- Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the 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, voice gets deeper, urinating more often than usual, nausea or vomiting, 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, neck stiffness
- Inflammation of the Eyes – Signs and symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
- Severe Infections – Signs and symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, 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, and back or neck pain, swelling of face or lips
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
- 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
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- 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
Patients should tell their healthcare provider about all the medicines they 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
TECENTRIQ may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.
Report side effects to 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 visit http://www.Tecentriq.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
References
- American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.
- National Cancer Institute. SEER Stat Fact Sheets: Bladder Cancer. http://seer.cancer.gov/statfacts/html/urinb.html. Accessed November 17, 2016.
- TECENTRIQ (atezolizumab) Prescribing Information. Genentech, Inc. 2017.
- Balar AV, Galsky MD, Rosenberg JE, et al. (2016). Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial. The Lancet.
