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
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 SIGNIFICANTLY REDUCED
THE CHANCE OF LUNG CANCER SPREADING
IMFINZI may not work for everyone.