National Geographic : 2019 Jun
IMFINZI was studied in 713 patients with unresectable Stage 3 NSCLC who completed at least 2 cycles of chemotherapy that contained platinum given at the same time (concurrent) as radiation before starting the trial. Patients in the study had good performance status (WHO 0 or 1). IMFINZI was tested against placebo (no medication). The main goal of the trial was to measure the length of time people remained progression free (without cancer growing or spreading) and overall survival. At the time of analysis, overall survival comparison was not yet available. This trial is still ongoing. WHO IS IMFINZI FOR? IMFINZI® (durvalumab) is a prescription medicine used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. It is not known if IMFINZI is safe and effective in children. IMPORTANT SAFETY INFORMATION What is the most important information I should know about IMFINZI? IMFINZI is a medicine that may treat a type of lung cancer by working with your immune system. IMFINZI 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 develop any symptoms of the following problems or if these symptoms get worse: Lung problems (pneumonitis). Signs and symptoms may include new or worsening cough, shortness of breath, and chest pain. Liver problems (hepatitis). Signs and symptoms 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 may include diarrhea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness. Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas). 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; feeling cold; constipation; your voice gets deeper; urinating more often than usual; nausea or vomiting; stomach-area (abdomen) pain; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness. Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include decrease in the amount of urine, blood in your urine, swelling of your ankles, and loss of appetite. Skin problems. Signs may include rash, itching, and skin blistering. Problems in other organs. Signs and symptoms may include neck stiffness; headache; confusion; fever; chest pain, shortness of breath, or irregular heartbeat (myocarditis); changes in mood or behavior; low red blood cells (anemia); excessive bleeding or bruising; muscle weakness or muscle pain; blurry vision, double vision, or other vision problems; and eye pain or redness. IMFINZI is a registered trademark of the AstraZeneca group of companies. ©2018 AstraZeneca. All rights reser ved. US -12936 7/18 Severe infections. Signs and symptoms may include fever, cough, frequent urination, pain when urinating, and flu-like symptoms. Severe infusion reactions. Signs and symptoms may include chills or shaking, itching or rash, flushing, shor tness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and facial swelling. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with IMFINZI if you have severe side effects. Before you receive IMFINZI, 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; or are being treated for an infection. If you are pregnant or plan to become pregnant, tell your healthcare provider. IMFINZI 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 3 months after the last dose of IMFINZI. Talk to your healthcare provider about which birth control methods to use. Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI. If you are breastfeeding or plan to breastfeed, tell your healthcare provider. It is not known if IMFINZI passes into breast milk. Do not breastfeed during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI. Tell your healthcare provider about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of IMFINZI? IMFINZI can cause serious side effects (see earlier). The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs (pneumonitis), upper respiratory tract infections, shor tness of breath, and rash. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA .gov/medwatch or call 1-800 -FDA -1088. Please see Brief Summary of complete Prescribing Information on the following page. If you cannot afford your medications, AstraZeneca may be able to help. Visit AstraZeneca-us.com to find out how. IMFINZI is an immunotherapy. People receiving IMFINZI had a 48% lower chance of lung cancer growing or spreading than those receiving placebo (no medicine). It was also proven to give people 3x more time without their cancer spreading compared with placebo. * Before IMFINZI, the last 10 years showed only limited advancements to the current standard of care for unresectable Stage 3 NSCLC. IMFINZI SIGNIFICANTLY REDUCED THE CHANCE OF LUNG CANCER SPREADING IMFINZI may not work for everyone. *In a clinical trial, the median time tumors did not grow or spread was 16.8 months for the 476 patients receiving IMFINZI compared with 5.6 months for the 237 patients receiving placebo. Median is the middle number in a group of number s arr anged from lowest to highest . Individual results may var y. ASK YOUR DOCTOR ABOUT IMFINZI. VISIT IMFINZI.COM FIRST & ONLY TREATMENT APPROVED for people with unresectable Stage 3 non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent chemoradiation therapy (CRT).