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INLYTA Clinical Trial Results

INLYTA Clinical Trial Results

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 significantly extended median progression-free survival (PFS) for some advanced RCC patients compared with others taking Nexavar® (sorafenib).

What does "significantly extended" mean?

It means the results of the INLYTA trial did not happen by chance. Rather, the increase in progression-free survival seen in INLYTA patients was due to the effect of the medicine in INLYTA. And you and your doctor can feel confident about these results.

What is progression-free survival (PFS)?

Progression-free survival is one way to check how effective a treatment is. It is a measure of the activity of a treatment on cancer. It is the length of time during and after cancer treatment that a patient lives without the disease worsening.

In a clinical trial with 723 patients, INLYTA significantly increased median progression-free survival for some patients versus Nexavar

Delayed progression

On average, INLYTA delayed cancer progression 43% longer than Nexavar.
  • Patients taking INLYTA experienced a median PFS of 6.7 months. This is compared with 4.7 months for those taking Nexavar

Decreased risk

In the same trial, INLYTA decreased the risk of disease progression by 33%.
  • Disease progression includes tumor growth, tumor spread, or death

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

What these results may mean to you

In this clinical trial it was shown that INLYTA patients were likely to achieve longer progression-free survival. This is compared to patients who took Nexavar. Based on the outcomes of this trial, you may experience similar results if you take INLYTA.

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. Overall survival was similar between INLYTA and Nexavar patients.

More than twice as many patients taking INLYTA saw their tumors shrink (overall response rate)

This includes patients whose tumors shrank 30% or more and whose response lasted at least 4 weeks.

Reduced tumor size
  • More than twice as many patients on INLYTA saw their tumors shrink (70 of 361 patients taking INLYTA compared with 34 of 362 patients taking Nexavar)
  • On average, tumor size was reduced within about 12 weeks

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.

Scroll for Important Safety Information and Indication

IMPORTANT SAFETY INFORMATION

What is INLYTA?

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.

It is not known if INLYTA is safe or effective in children.

What should I tell my doctor before taking INLYTA?

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

For females, tell your doctor if you:

  • are pregnant or plan to become pregnant. Taking INLYTA during pregnancy can cause the death of an unborn baby or birth defects. You should not become pregnant while taking INLYTA. Talk to your doctor if you are pregnant or plan to become pregnant
  • are able to become pregnant. You should use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods to prevent pregnancy while you are taking INLYTA
  • are breastfeeding or plan to breastfeed. It is not known if INLYTA passes into your breast milk. You and your doctor should decide if you will take INLYTA or breastfeed. You should not do both

For males:

  • use effective birth control during your treatment with INLYTA. Talk to your doctor about birth control methods
  • if your female partner becomes pregnant while you are taking INLYTA, tell your doctor right away

Tell your doctor 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.

Especially tell your doctor if you take:

  • dexamethasone
  • bosentan
  • modafinil
  • St. John’s wort (Hypericum perforatum)
  • Medicine for:

    • asthma
    • tuberculosis
    • seizures
    • bacterial infections
    • fungal infections
    • depression
    • HIV or AIDS

Ask your doctor or pharmacist if you are not sure if your medicine is one listed above. If you are taking any medicines for the conditions listed above, your doctor might need to prescribe a different medicine or your dose of INLYTA may need to be changed. Talk with your doctor before you start taking any new medicine.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I take INLYTA?

  • Take INLYTA exactly as prescribed by your doctor
  • Your doctor may change your dose if needed
  • INLYTA can be taken with or without food
  • Take INLYTA 2 times a day about 12 hours apart
  • Swallow INLYTA tablets whole with a glass of water
  • Your doctor should check your blood pressure regularly during treatment with INLYTA
  • If you vomit or miss a dose of INLYTA, take your next dose at your regular time. Do not take two doses at the same time
  • If you take too much INLYTA, call your doctor or go to the nearest hospital emergency room right away

What should I avoid while taking INLYTA?

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

What are the possible side effects of INLYTA?

INLYTA may cause serious side effects, including:

  • High blood pressure (hypertension). 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. INLYTA can cause blood clots which 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). 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 (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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This product’s label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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