(BPT) - First FDA-approved treatment option in 20 years for adults with previously untreated extensive-stage small cell lung cancer.
This year, more than 228,000 Americans are estimated to be diagnosed with lung cancer.1 In recent years, there has been limited progress in treatment for people who have an aggressive form of disease called extensive-stage small cell lung cancer (ES-SCLC).2,3,4 In fact, for people newly diagnosed with ES-SCLC, the only initial treatment option has been chemotherapy — until now.5,6,7
The U.S. Food and Drug Administration (FDA) recently approved the cancer immunotherapy Tecentriq® (atezolizumab) in combination with carboplatin and etoposide as an initial treatment for adults with ES- SCLC.6 It is the first and only cancer immunotherapy approved by the FDA for this type of disease.6
“The approval of Tecentriq in combination with chemotherapy is wonderful news for people with this particularly difficult-to-treat form of lung cancer,” said Alan Sandler, M.D., senior vice president of Oncology Global Product Development, Genentech. “Small cell lung cancer has not seen a new initial treatment option approved by the FDA in 20 years, and we now have an approved immunotherapy that when added to chemotherapy may help people diagnosed with this type of lung cancer live longer than if they received chemotherapy alone.”
So what exactly is ES-SCLC, and who does it commonly affect?
There are two major types of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). SCLC affects fewer people than NSCLC and is particularly difficult to treat because it can progress more rapidly than NSCLC.2,7,8 As a result, the majority of people with SCLC are diagnosed with extensive-stage disease, when the disease has spread further in the lungs or other parts of the body.9,10
Smoking is the leading risk factor for most types of lung cancer, especially SCLC, which is almost exclusively associated with its use. Other major risk factors include advanced age, environmental exposure to radon gas or asbestos or other cancer-causing substances in the workplace, air pollution, arsenic in drinking water, radiation therapy to the lungs, or a personal or family history of lung cancer.11
It’s important to pay attention to potential signs and symptoms of SCLC. The most common include a persistent cough that does not go away or gets worse, coughing up blood, weight loss or loss of appetite, shortness of breath, and new onset of wheezing. Symptoms usually do not appear until the cancer is advanced, which helps explain why so many people with SCLC are diagnosed when the disease is in the extensive-stage.10
“If you or a loved one are at risk for lung cancer or are experiencing any potential symptoms, talk to a doctor and ask about screening,” said Sandler.
If you or a loved one are diagnosed with lung cancer, Dr. Sandler also stresses the importance of seeking support from family, friends or people who are specialized in helping people with lung cancer. Patient advocacy organizations can connect people newly diagnosed with lung cancer with other patients and provide additional resources for loved ones. Even though everyone’s lung cancer journey is unique, support from others with the same type of cancer can help patients and their families navigate their diagnosis.
For more information about SCLC, visit https://www.gene.com/topics/lung-cancer.
Important Safety Information and Indications
What is TECENTRIQ?
TECENTRIQ is a prescription medicine used to treat adults with:
A type of lung cancer called non-small cell lung cancer (NSCLC).
- TECENTRIQ may be used with bevacizumab and the chemotherapy medicines carboplatin and paclitaxel as your first treatment when your lung cancer:
- has spread or grown, and
- is a type of lung cancer called “non-squamous NSCLC”, and
- your tumor does not have an abnormal “EGFR” or “ALK” gene
- TECENTRIQ may be used when your lung cancer:
- has spread or grown, and
- you have tried chemotherapy that contains platinum, and it did not work or is no longer working, and
- if your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working
A type of lung cancer called small cell lung cancer (SCLC).
- TECENTRIQ may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:
- is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown
It is not known if TECENTRIQ is safe and effective in children.
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
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.
1American Cancer Society Cancer Facts & Figures 2019. [Internet]: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2019/cancer-facts-and-figures-2019.pdf. Accessed March 2019.
2Sabari JK, Lok BH, Laird JH, Poirier JT, Rudin CM. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14:549-561.
3Hematology/Oncology (Cancer) Approvals & Safety Notifications 2013-2016. [Internet]: http://wayback.archive-it.org/7993/20170111064250/http:/www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed March 2019.
4Hematology/Oncology (Cancer) Approvals & Safety Notifications 2018-2019. [Internet]: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm. Accessed March 2019.
5American Cancer Society; Treatment Choices By Stage Of Small Cell Lung Cancer [Internet]: https://www.cancer.org/cancer/small-cell-lung-cancer/treating/by-stage.html. Accessed March 2019.
6Tecentriq (atezolizumab) Prescribing Information. Genentech, Inc. 2019.
7Byers LA, Rudin CM. Small cell lung cancer: where do we go from here? Cancer. 2015;121:664-672.
8American Cancer Society; What Is Non-Small Cell Lung Cancer? [Internet]: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html. Accessed March 2019.
9American Cancer Society; Small Cell Lung Cancer Stages. [Internet]: https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/staging.html. Accessed March 2019.
10American Cancer Society; Signs And Symptoms Of Small Cell Lung Cancer. [Internet]: https://www.cancer.org/cancer/small-cell-lung-cancer/detection-diagnosis-staging/signs-symptoms.html. Accessed March 2019.
11American Cancer Society; Small Cell Lung Cancer Risk Factors [Internet]: https://www.cancer.org/cancer/small-cell-lung-cancer/causes-risks-prevention/risk-factors.html. Accessed March 2019.