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INLYTA Clinical Trial Results

INLYTA Clinical Trial Results

ABOUT INLYTA

INLYTA Clinical Trial Results

In a head-to-head clinical trial, researchers studied progression-free-survival (PFS) in 361 patients taking INLYTA versus 362 patients taking Nexavar® (sorafenib). Progression-free survival is the length of time during and after cancer treatment that a patient lives without the disease worsening. This is one way to check how effective the treatment is. The study showed that:

INLYTA extended median PFS by 43% compared to Nexavar

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INLYTA extended median PFS by 43% compared to Nexavar

Patients taking INLYTA experienced a median PFS of 6.7 months compared with 4.7 months for those taking Nexavar. That’s a 2-month increase in median PFS.

INLYTA also decreased the overall risk of disease progression by 33% compared to Nexavar

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INLYTA also decreased the overall risk of disease progression by 33% compared to Nexavar

Disease progression includes tumor growth, tumor spread, and death.

INLYTA reduced tumor size in twice as many patients compared with Nexavar (overall response rate)

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INLYTA reduced tumor size in twice as many patients compared with Nexavar (overall response rate)

70 of 361 patients taking INLYTA saw their tumors shrink compared to 34 of 362 patients taking Nexavar. This includes patients whose tumors shrank 30% or more and whose response to treatment lasted at least 4 weeks.

Along with progression-free survival, this study also measured overall survival (OS). This is 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.

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

Nexavar is a registered trademark of Bayer Pharmaceuticals Corporation.

IMPORTANT SAFETY INFORMATION

Before taking INLYTA, tell your healthcare provider about all of your medical conditions, including 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 problems, including heart failure
  • have an unhealed wound
  • plan to have surgery or have had a recent surgery. You should stop taking INLYTA for at least 2 days before planned surgery

For females, tell your healthcare provider if you:

  • are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can harm your unborn baby. You should not become pregnant during treatment with INLYTA.
  • are able to become pregnant. You should have a pregnancy test before you start treatment with INLYTA. Use effective birth control during treatment and for 1 week after your last dose of INLYTA. Talk to your healthcare provider about birth control methods that you can use to prevent pregnancy during this time.
  • are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of INLYTA.

For males with female partners who are able to become pregnant:

  • use effective birth control during treatment and for 1 week after your last dose of INLYTA.
  • if your female partner becomes pregnant during your treatment with INLYTA, tell your healthcare provider right away.

INLYTA may cause fertility problems in males and females, which may affect your ability to have a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider 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 healthcare provider before you start taking any new medicine. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Do not drink grapefruit juice or eat grapefruit. Grapefruit may increase the amount of INLYTA in your blood.

INLYTA may cause serious side effects, including:

  • High blood pressure (hypertension). High blood pressure is common with INLYTA and may sometimes be severe. Your healthcare provider should check your blood pressure regularly during treatment with INLYTA. If you develop blood pressure problems, your healthcare provider may prescribe medicine to treat your high blood pressure, lower your dose, or stop your treatment with INLYTA
  • Blood clots in your veins or arteries. INLYTA can cause blood clots which can be serious, and sometimes lead to death. Get emergency help and call your healthcare provider 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 healthcare provider 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 healthcare provider should check you 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 healthcare provider 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). A tear in your stomach or intestinal wall can be serious and can sometimes lead to death. Get medical help right away if you get the following symptoms:

    • severe stomach-area (abdominal) pain or stomach-area pain that does not go away
    • vomit blood
    • red or black stools
  • Thyroid gland problems. Your healthcare provider should do blood tests to check your thyroid gland function before and during your treatment with INLYTA. Tell your healthcare provider 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
  • Risk of wound healing problems. Wounds may not heal properly during INLYTA treatment. Tell your healthcare provider if you plan to have any surgery before starting or during treatment with INLYTA.

    • You should stop taking INLYTA at least 2 days before planned surgery
    • Your healthcare provider should tell you when you may start taking INLYTA again after surgery
  • Reversible Posterior Leukoencephalopathy Syndrome (RPLS). A condition called reversible posterior leukoencephalopathy syndrome (RPLS) can happen during treatment with INLYTA. Call your healthcare provider right away if you get:

    • headache
    • seizures
    • weakness
    • confusion
    • high blood pressure
    • blindness or change in vision
    • problems thinking
  • Protein in your urine. Your healthcare provider should check your urine for protein before and during your treatment with INLYTA. If you develop protein in your urine, your healthcare provider may decrease your dose of INLYTA or stop your treatment.

  • Liver problems. Your healthcare provider will do blood tests before and during your treatment with INLYTA. Your healthcare provider may delay or stop your treatment with INLYTA if you develop severe liver problems.

The most common side effects of INLYTA include:

  • diarrhea
  • feeling tired or weak
  • decreased appetite
  • nausea
  • hoarseness
  • rash, redness, itching or peeling of your skin on your hands and feet
  • decreased weight
  • vomiting
  • constipation

These are not all of the possible side effects of INLYTA. 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.

INDICATION

INLYTA is a prescription medicine used to treat kidney cancer that has spread or cannot be removed by surgery (advanced renal cell carcinoma or RCC) when 1 prior drug treatment regimen for your RCC has not worked.
It is not known if INLYTA is safe and effective in children.

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