How ZYNYZ was studied
ZYNYZ was evaluated in a clinical study in people with MCC that had spread or returned (advanced MCC). The initial assessment that led to the approval of ZYNYZ included 65 people with advanced MCC. Some people in the study had prior surgery or radiation therapy for their MCC. None of the 65 people in the initial assessment received prior therapies like chemotherapy.
- People could not take part in the study if their immune system function was changed by medicines they were receiving (called immunosuppressants) or by an active autoimmune disease
- People who were HIV-positive could take part in the study if they had an undectable viral load, an appropriate CD4+ count, and were receiving appropriate treatment
The study measured:
The number of people who saw their MCC lesions disappear* (complete response) or shrink in size by a certain amount (partial response) during treatment with ZYNYZ. This was the primary measurement in the study.
How long their response to treatment with ZYNYZ lasted. This is called the duration of response. This was a secondary measurement in the study.
*Disappearance of all signs of cancer in response to treatment does not always mean the cancer has been cured.
HIV, human immunodeficiency virus.
ZYNYZ may help treat your MCC
ZYNYZ was shown to be effective in people with MCC that had spread or returned
Receiving ZYNYZ
What is the most important information I should know about ZYNYZ?
ZYNYZ is a medicine that may treat a certain type of skin cancer by working with your immune system. ZYNYZ 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 severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Call or see your doctor right away if you develop any new or worsening signs or symptoms, including:
Lung problems: cough, shortness of breath, chest pain
Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdomen) pain or tenderness
Liver problems: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, loss of appetite
Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in your mouth or nose, throat, or genital area; fever or flu-like symptoms; swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with ZYNYZ. Call or see your doctor right away for any new or worsening signs or symptoms, which may include:
- chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
- confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- persistent or severe muscle pain or weakness, muscle cramps
- low red blood cells, bruising
Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, back or neck pain
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with ZYNYZ. Your doctor will monitor you for these complications.
Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during your treatment with ZYNYZ. Your doctor may treat you with corticosteroid or hormone replacement medicines and may also need to delay or completely stop treatment if you have severe side effects.
Before you receive ZYNYZ, tell your doctor about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have received radiation treatment to your chest area
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to become pregnant. ZYNYZ can harm your unborn baby
Females who are able to become pregnant:
- Your doctor should do a pregnancy test before you start treatment.
- You should use an effective method of birth control during your treatment and for 4 months after your last dose. Talk to your doctor about birth control methods that you can use during this time.
- Tell your doctor right away if you become pregnant or think you may be pregnant during treatment.
- are breastfeeding or plan to breastfeed. It is not known if ZYNYZ passes into your breast milk. Do not breastfeed during treatment and for 4 months after your last dose.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of ZYNYZ include tiredness, muscle and bone pain, itching, diarrhea, rash, fever, nausea
These are not all the possible side effects of ZYNYZ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ZYNYZ
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about ZYNYZ, talk with your doctor. You can ask your doctor for information about ZYNYZ that is written for health professionals.
