INLYTA Study Results
Efficacy of treatment

INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked or has stopped working. This is often referred to as second-line treatment.)

Results from a head-to-head clinical trial

In a trial, INLYTA extended median progression-free survival (PFS) for some advanced RCC patients compared with others taking Nexavar® (sorafenib).

  • Extended median (PFS) by 2 months compared to Nexavar In this study, those who were treated with INLYTA experienced a median PFS of 6.7 months compared with 4.7 months among patients who were taking Nexavar. That’s a 43% increase in median PFS.
  • One-third less risk of progression In this study, the overall risk of disease progression, such as tumor growth or spread, or death, was decreased by about one-third with INLYTA compared to Nexavar.
  • Neither medicine showed an advantage in overall survival This study also measured the total time patients on each medicine remained alive after starting treatment.. There was no significant difference in overall survival between the patients taking INLYTA and the patients taking Nexavar.
  • More than twice as many INLYTA patients saw their tumors shrink (overall response rate) Twice as many patients on INLYTA saw their tumors shrink (70 of 361 patients taking INLYTA compared with 34 of 362 patients taking Nexavar).

INLYTA is not a cure. The data represent an average and not all patients may experience the same results.

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Nexavar is a registered trademark of Bayer Pharmaceuticals Corporation.
Kidney

One of a pair of organs that removes waste products from the blood. In the process, they make urine to help carry waste out of the body. One is on the left side of the abdomen. The other is on the right side.

Advanced renal cell carcinoma (ad-VANST REE-null SELL kar-sin-O-muh)

Renal cell carcinoma is the most common form of cancer that starts in the kidneys. When the cancer spreads from the kidneys to other parts of the body, it is called advanced renal cell carcinoma.

Renal cell carcinoma (RCC) (REE-null SELL kar-sin-O-muh)

The most common form of cancer that starts in the kidneys.

Second-line treatment

A therapy prescribed when your first drug treatment has not worked or has stopped working.

Median

The median is a kind of average. Median PFS means that half of the patients in a study experienced longer PFS and half experienced shorter PFS.

Progression-free survival (PFS)

One measure of how a cancer treatment is working is what’s known as progression-free survival or PFS. This term refers to the length of time, from the start of treatment, that patients remain alive and their disease does not worsen.

Tumor (TOO-mor)

A mass of cancer cells.

Overall survival

This is another measure of how a cancer treatment is working. It is the length of time that patients remain alive after starting treatment. This number includes all causes of death (cancer, treatment side effects, and other causes). It also includes time spent on later treatments.

Overall response rate

Another measure of how a cancer treatment is working is tumor shrinkage. This rate includes patients whose tumors shrank 30% or more and whose response lasted for at least 4 weeks. Doctors refer to tumor shrinkage as the overall tumor response rate.

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Important safety information

Before you take INLYTA, tell your doctor if you:

  • Have high blood pressure
  • Have thyroid problems
  • Have liver problems
  • Have a history of blood clots in your veins or arteries (types of blood vessels), including stroke, heart attack, or change in vision
  • Have any bleeding problems
  • Have a history of heart failure
  • Have an unhealed wound
  • Plan to have surgery. You should stop taking INLYTA at least 24 hours before planned surgery
  • Have any other medical conditions

Tell your doctor and pharmacist about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INLYTA and certain other medicines can affect each other causing serious side effects. Talk with your doctor before you start taking any new medicine. Especially tell your doctor if you take dexamethasone, bosentan, modafinil, St. John's wort (Hypericum perforatum), or medicine for asthma, tuberculosis, seizures, bacterial infections, fungal infections, depression, or HIV/AIDS.

Do not drink grapefruit juice or eat grapefruit.

Pregnancy and breastfeeding. Women should not take INLYTA if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Taking INLYTA during pregnancy can cause death of an unborn baby or birth defects. Both men and women taking INLYTA should use effective birth control during treatment with INLYTA. Talk to your doctor about birth control methods, or if you are pregnant or plan to become pregnant.

INLYTA may cause serious side effects, including:

High blood pressure (hypertension). In a clinical study, hypertension occurred as early as 4 days into treatment. On average, this increase was seen within the first month of treatment. Your doctor should check your blood pressure regularly during treatment with INLYTA.
If you develop blood pressure problems, your doctor may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA.

Problem with blood clots in your veins or arteries. Because this can be serious and sometimes lead to death, get emergency help and call your doctor if you get any of the following symptoms:

  • Chest pain or pressure
  • Pain in your arms, back, neck or jaw
  • Shortness of breath
  • Numbness or weakness on one side of your body
  • Trouble talking
  • Headache
  • Vision changes

Bleeding. INLYTA can cause bleeding which can be serious, and sometimes lead to death. Call your doctor right away or get medical help if you develop any of the following signs or symptoms:

  • Unexpected bleeding or bleeding that lasts a long time, such as:
    • Unusual bleeding from the gums
    • Menstrual bleeding or vaginal bleeding that is heavier than normal
    • Bleeding that is severe or you cannot control
    • Pink or brown urine
    • Red or black stools (looks like tar)
    • Bruises that happen without a known cause or get larger
    • Cough up blood or blood clots
    • Vomit blood or your vomit looks like "coffee grounds"
  • Unexpected pain, swelling, or joint pain
  • Headaches, feeling dizzy or weak

Heart failure. Your doctor should check for signs or symptoms of heart failure regularly during treatment with INLYTA. Heart failure can be serious and can sometimes lead to death. Tell your doctor if you have any of the following symptoms during your treatment with INLYTA:

  • Tiredness
  • Swelling of your stomach area (abdomen), legs, or ankles
  • Shortness of breath
  • Protruding neck veins

Tear in your stomach or intestinal wall (perforation). Because this can be serious and sometimes lead to death, get medical help right away if you get the following symptoms:

  • Severe stomach (abdominal) pain or stomach pain that does not go away
  • Vomit blood
  • Red or black stools

Thyroid gland problems. Your doctor should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your doctor if you have any of the following symptoms during your treatment with INLYTA:

  • Tiredness that worsens or that does not go away
  • Feeling hot or cold
  • Your voice deepens
  • Weight gain or weight loss
  • Hair loss
  • Muscle cramps and aches

Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen while taking INLYTA. Call your doctor right away if you get:

  • Headache
  • Seizures
  • Weakness
  • Confusion
  • High blood pressure
  • Blindness or change in vision
  • Problems thinking

Increased protein in your urine. Your doctor should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your doctor may decrease your dose of INLYTA or stop your treatment.

Change in liver function. Your doctor should do blood tests before and during your treatment with INLYTA to check your liver function.

The most common side effects of INLYTA include:

  • Diarrhea (frequent or loose bowel movements)
  • High blood pressure
  • Tiredness or feeling weak
  • Decreased appetite
  • Nausea
  • Hoarseness
  • Rash, redness, itching or peeling of your skin on your hands or feet
  • Decreased weight
  • Vomiting
  • 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 INLYTA. For more information, ask your doctor or pharmacist.

INDICATION

INLYTA is a prescription medicine used to treat advanced kidney cancer (advanced renal cell carcinoma or RCC) when one prior drug treatment for this disease has not worked or has stopped working.

Please see full Prescribing Information and Patient Information, including a complete discussion of the risks of INLYTA.

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.