New treatment option for previously treated advanced stage lung cancer
(BPT) - Cancer claims the lives of half a million Americans every year. While the rates of certain cancers have declined due to earlier diagnosis and prevention efforts, lung cancer remains the leading cause of cancer deaths in the U.S., resulting in more deaths each year than prostate, breast and colorectal cancers combined. In 2015 alone, more than 220,000 people in the U.S. are expected to be diagnosed with lung cancer.
There are several types of lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is one of the most common types of the disease and accounts for approximately 85 percent of cases. A subtype of NSCLC is known as squamous cell NSCLC, which accounts for approximately 25 to 30 percent of all lung cancers.
Historically, lung cancer has been difficult to treat because it is harder to detect in its earlier stages; and the initial symptoms can be mistaken for another illness. In fact, only 15 percent of lung cancer cases are diagnosed at an early stage. Oftentimes, the cancer has already begun to spread and become advanced before a patient notices any symptoms. Over half of people with lung cancer die within one year of being diagnosed.
“Lung cancer is one of the most commonly diagnosed forms of cancer, where despite several advancements over the years, there continues to remain an unmet need to improve clinical outcomes for patients,” said Dr. Suresh Nair, medical oncologist at Lehigh Valley Health Network. “However, that may be changing, as, we now have additional treatment options that provide patients and physicians new ways of fighting the disease and offer renewed sense of hope within the lung cancer community.”
In March 2015, the U.S. Food & Drug Administration (FDA) approved Opdivo, also known as nivolumab, for adults with advanced squamous NSCLC previously treated with platinum-based chemotherapy.
Opdivo is an immunotherapy, which works with your own immune system and is the first-ever immunotherapy for this type of advanced lung cancer. For the first time in 15 years, a single treatment has been shown to increase survival versus chemotherapy (docetaxel) for previously-treated advanced squamous NSCLC patients. Opdivo is the first FDA-approved drug to accomplish this.
Opdivo was studied in a clinical trial that included 272 patients with advanced squamous NSCLC whose cancer has spread or grown after treatment with platinum-based chemotherapy. In the clinical trial, 135 patients were assigned to receive Opdivo and 137 were assigned to receive chemotherapy (docetaxel). Half of the patients on Opdivo were still alive at 9.2 months, compared to 6 months with chemotherapy (docetaxel). Opdivo will not work for every patient. Individual results may vary. It is important for patients to ask their doctors if Opdivo is right for them.
Opdivo can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems (pneumonitis), intestinal problems (colitis), liver problems (hepatitis), kidney problems, including nephritis and kidney failure, hormone gland problems (especially the thyroid, pituitary, and glands), and problems in other organs.
The most common side effects of Opdivo in people with squamous NSCLC are feeling tired; shortness of breath; pain in muscles, bones, and joints; decreased appetite; cough; nausea; and constipation.
Marvin Wright of Whitehall, PA, was diagnosed with advanced squamous NSCLC previously treated with platinum-based chemotherapy that had spread (metastasized) throughout his body.
“I had been through previous treatments, but the cancer kept coming back. I talked with my doctor and family about different treatment options and we decided to try a new therapy that works with my immune system,” said Wright. “This drug has given me hope, and I want to encourage other patients to talk with their doctor and learn about potential treatment options that may be available to help them live longer.”
If you or someone you know has previously treated advanced squamous NSCLC, talk to your healthcare provider about Opdivo to see if it might be a treatment option for you. To learn more, visit www.opdivo.com.
INDICATION
OPDIVO® (injection for intravenous use 10 mg/mL) is a prescription medicine used to treat a type of advanced stage lung cancer (squamous non-small cell lung cancer) that has spread or grown after treatment with platinum-based chemotherapy.
It is not known if OPDIVO is safe and effective in children less than 18 years of age.
IMPORTANT SAFETY INFORMATION
OPDIVO® (nivolumab) is a medicine that may treat your lung cancer by working with your immune system. OPDIVO 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. These problems may happen anytime during treatment or even after your treatment has ended.
Serious side effects may include:
* Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
* Intestinal problems (colitis) that can lead to tears or holes in your intestine. 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.
* 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 bruise more easily than normal; and feeling less hungry than usual.
* Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
* Hormone gland problems (especially the thyroid, pituitary, and glands). 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; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; dizziness or fainting; hair loss; feeling cold; constipation; and voice gets deeper.
* Problems in other organs. Signs of these problems include: rash; changes in eyesight; severe or persistent muscle or joint pains; and severe muscle weakness.
Getting medical treatment right away may keep these problems from becoming more serious.
Your doctor will check you for these problems during treatment with OPDIVO. Your doctor may treat you with corticosteroid medicines and delay or completely stop treatment with OPDIVO, if you have severe side effects.
Pregnancy and Nursing:
Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your doctor about birth control methods that you can use during this time. Tell your doctor right away if you become pregnant during treatment with OPDIVO. Before receiving OPDIVO, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment with OPDIVO.
Tell your healthcare provider about:
* Your health problems or concerns 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; or have any other medical conditions
* All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements
The most common side effects of OPDIVO in people with squamous non-small cell lung cancer include: feeling tired; shortness of breath; pain in muscles, bones, and joints; decreased appetite; cough; nausea; and constipation.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of OPDIVO. For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatchor call 1-800-FDA-1088.
Please see the U.S. FULL PRESCRIBING INFORMATION and MEDICATION GUIDE for OPDIVO®.
*Bristol-Myers Squibb does not endorse these organizations. The information/links provided are meant for informational purposes only and are not meant to replace a physician's medical advice.