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MISSION, Kan., July 28, 2020 (GLOBE NEWSWIRE) -- (Family Features) Despite progress in treating lung cancer, it is the leading cause of cancer deaths and impacts communities across the United States. The most common form of lung cancer is non-small cell lung cancer (NSCLC). NSCLC is a complex disease that can be challenging to treat, which may feel overwhelming and unsettling for people facing the disease.
Advanced lung cancer is devastating, so the fact that additional treatment options are now available that have the potential to extend the lives of patients gives us hope, said Bonnie J. Addario, lung cancer survivor and co-founder and chair, GO2 Foundation. Its exciting that this is a combination of immunotherapies, which brings a whole new approach for patients and physicians to consider when discussing treatment options.
A Chemo-Free Treatment Option A first-of-its-kind, chemotherapy-free treatment option was recently approved by the U.S. Food and Drug Administration as a first treatment for certain adults with advanced NSCLC, or NSCLC that has spread to other parts of the body. This treatment is a prescription medicine that is a combination of two immunotherapies, Opdivo (nivolumab) and Yervoy (ipilimumab), and it can be used for adults newly diagnosed with advanced NSCLC that tests positive for PD-L1 but do not have an abnormal EGFR or ALK gene.
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) that can lead to tears or holes in your intestine; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; severe infusion reactions; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Additional serious side effects of Yervoy alone include: nerve problems that can lead to paralysis; eye problems; and complications of stem-cell transplant that uses donor stem cells (allogeneic). Please see Important Facts about side effects for Opdivo and Yervoy below.
The Chance for a Longer Life In a study of 793 previously untreated patients whose tumors tested positive for PD-L1, 396 were given the immunotherapy combination of Opdivo + Yervoy and 397 were given platinum-based chemotherapy. Treatment with the immunotherapy combination reduced the risk of death by 21%, with half of patients treated with the immunotherapy combination still alive at 17.1 months and half of patients treated with platinum-based chemotherapy still alive at 14.9 months. This analysis was conducted at a minimum follow-up of 29.3 months.
In additional analyses, 63% of patients treated withthe immunotherapy combinationand 56% treated with platinum-based chemotherapy were alive at one year, and 40% and 33% at two years, respectively.At three years, 33% of patients treated withthe immunotherapy combination and 22% of those treated with platinum-based chemotherapy were still alive. The analysis at these time points was not designed to show a difference between Opdivo + Yervoy and platinum-based chemotherapy.
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep. Please see Important Facts about side effects for Opdivo and Yervoy below.
As an oncologist who treats patients facing this particularly challenging disease, the fact that Opdivo plus Yervoy has shown overall survival at three years is important, said Hossein Borghaei, D.O., chief of thoracic medical oncology division at Fox Chase Cancer Center and an investigator in the clinical study.
Being diagnosed with lung cancer can be challenging and life-changing. Advancements in NSCLC bring additional treatment options that may enable certain patients a chance to live longer lives.
For more information, visit Opdivo.com or talk to you doctor about treatment options.
INDICATIONOpdivo (nivolumab) is a prescription medicine used in combination with Yervoy (ipilimumab) as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
It is not known if OPDIVO is safe and effective in children younger than 18 years of age.
OPDIVO (10 mg/mL) and YERVOY (5 mg/mL) are injections for intravenous (IV) use.
IMPORTANTSAFETYINFORMATION forOPDIVO(nivolumab) + YERVOY(ipilimumab)
OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area 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. Some of these problems may happen more often when OPDIVO is used in combination with YERVOY.
YERVOY can cause serious side effects in many parts of your body which can lead to death. These problems may happen anytime during treatment with YERVOY or after you have completed treatment.
Serious side effects may include:
Additional serious side effects observed during a separate study of YERVOY alone include:
Get medical help immediatelyif you develop any of these symptoms or they get worse. It may keep these problems from becoming more serious. Your healthcare team will check you for side effects during treatment and may treat you with corticosteroid or hormone replacement medicines. If you have a serious side effect, your healthcare team may also need to delay or completely stop your treatment.
OPDIVO and OPDIVO + YERVOY can cause serious side effects, including:
Pregnancy and Nursing:
Tell your healthcare provider about:
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection;headache; low thyroid hormone levels (hypothyroidism); decreased weight; and dizziness.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visitwww.fda.gov/medwatch or call 1-800-FDA-1088.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.
Michael Frenchmfrench@familyfeatures.com1-888-824-3337editors.familyfeatures.com
About Family Features Editorial SyndicateA leading source for high-quality food, lifestyle and home and garden content, Family Features provides readers with topically and seasonally relevant tips, takeaways, information, recipes, videos, infographics and more. Find additional articles and information at Culinary.net and eLivingToday.com.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/5c174110-3d0e-4a76-a2bc-46e0ebc4e6a5
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Advances in Treating Non-Small Cell Lung Cancer - GlobeNewswire
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