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Avastin is a cancer medicine that interferes with the growth of cancer cells by blocking the formation and growth of new blood vessels in the tumor which slows their growth.

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Avastin is used to treat a certain type of brain tumor as well as cancers of the kidney, colon, rectum, lung, or breast. It is usually given as part of a combination of cancer medicines.

Avastin may also be used for purposes other than those listed here.

Most important: Avoid having surgery while you are being treated with Avastin. You may have problems with wound healing, which could result in bleeding or infection.

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If you need to have any type of surgery, you will need to stop receiving Avastin for at least 4 weeks while your surgical incision heals.

Before being treated with Avastin, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, a history of stroke or blood clots, or an open wound.

Some people receiving a Avastin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chills, wheezing, or chest pain during the injection.

Call your doctor at once if you have serious side effects such as blood in your stools or vomit, sudden numbness or weakness (especially on one side of the body), sudden headache or confusion, problems with vision or speech, chest pain spreading to the arm or shoulder, shortness of breath, swelling, rapid weight gain, or flu symptoms.

Avastin can cause a rare but serious neurologic disorder affecting the brain. Symptoms include headache, confusion, vision problems, feeling light-headed, fainting, and seizure (blackout or convulsions). These rare symptoms may occur within hours of your first dose of Avastin, or they may not appear for up to a year after your treatment started. Call your doctor at once if you have any of these side effects.

To be sure Avastin is not causing harmful effects, your blood pressure will need to be tested on a regular basis. Your urine may also need to be tested. Do not miss any scheduled visits to your doctor.








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Avastin can affect a woman’s fertility (ability to have children). Talk to your doctor about your specific risks.

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For Immediate Release: Jan. 27, 2012
Media Inquiries: Stephanie Yao, 301-796-0394, stephanie.yao@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves Inlyta to treat patients with a type of advanced kidney cancer
Drug helps keep cancer from progressing

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Renal cell carcinoma is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. Inlyta is a pill that patients take twice a day.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options.”

Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation.

Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.

Inlyta is marketed by New York City-based Pfizer Inc.

For more information:

FDA: Office of Hematology and Oncology Products

FDA: Approved Drugs: Questions and Answers

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.