Dr. Michael Harrison: May 25, 2017

CANCER IMMUNOTHERAPY APPROVED AS INITIAL TREATMENT FOR CERTAIN PEOPLE WITH ADVANCED BLADDER CANCER 

** TECENTRIQ® (ATEZOLIZUMAB) GRANTED ACCELERATED APPROVAL BY FDA **1

Dr. Michael Harrison
Duke Cancer Center

Bladder cancer is the sixth most common cancer, but until just this past year treatment for the advanced form of the disease – when it has spread and becomes harder to treat – had no new treatments available in more than 30 years.2,3,4,5 Treatment options were further limited for up to half of people with advanced disease who may not be able to take a standard treatment called cisplatin chemotherapy. Now, people with advanced bladder cancer who may not be able to take cisplatin finally have a new potential option for their cancer.  Last month, the U.S. Food and Drug Administration (FDA) expanded the use for a medicine called TECENTRIQ for people with this specific type of previously untreated advanced bladder cancer. Bladder cancer is the most common type of urothelial carcinoma. Less common forms include cancers of the urethra, ureters and renal pelvis.7

TECENTRIQ may be used for people whose cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma), and who are not eligible to take cisplatin chemotherapy, or who have tried chemotherapy that contains platinum, and it did not work or is no longer working.1 It is not known if TECENTRIQ is safe and effective in children. It’s important to remember that every patient is different, so they should speak with their doctor about treatment options and side effects. Possible serious side effects with TECENTRIQ include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy, meningitis and encephalitis), eye problems (inflammation of the eyes), severe infections and severe infusion reactions.

TECENTRIQ is the first cancer immunotherapy approved for this type of advanced bladder cancer. Cancer immunotherapies are a type of medicine designed to work with a person’s own immune system to fight cancer. Immunotherapy may also affect normal cells.1

Leading oncologist Dr. Michael Harrison will talk about the importance of this approval for people who are diagnosed with advanced bladder cancer.

For more information about bladder cancer, please visit the Bladder Cancer Advocacy Network’s website at www.BCAN.org or the American Cancer Society’s website at www.cancer.org.

MORE ABOUT THE EXPERT

Dr. Harrison specializes in treating people with genitourinary cancers, such as bladder, prostate, testicular and kidney cancer. He is a clinical trial investigator in the Phase II IMvigor 210 study, which evaluated the safety and efficacy of TECENTRIQ in bladder cancer. 

FOR TECHNICAL INFORMATION PLEASE CONTACT RICHIE CHUANG AT 917-207-9978

This interview is courtesy of Genentech

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, back or neck pain, and 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
  • 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.

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1 TECENTRIQ (atezolizumab) Prescribing Information. Genentech, Inc. 2017.

2 American Cancer Society. Cancer Facts & Figures 2017. Atlanta: American Cancer Society; 2017.

3 Guancial EA, et al. Journal of Clinical Interventions in Aging. 2015;10:939-949. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4467651/. Accessed November 8, 2016.

4 National Cancer Institute. Drugs Approved for Bladder Cancer. http://www.cancer.gov/about-cancer/treatment/drugs/bladder. November 8, 2016.

5 CenterWatch. FDA Approved Drugs for Oncology. https://www.centerwatch.com/drug-information/fda-approved-drugs/therapeutic-area/12/oncology. Accessed November 8, 2016.

6 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.

7 American Cancer Society. What is bladder cancer? http://www.cancer.org/cancer/bladdercancer/detailedguide/bladder-cancer-what-is-bladder-cancer. Accessed November 8, 2016.

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