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FDA Approves New Use of Avastin Plus Fluoropyrimidine-Based Chemotherapy in Metastatic Colorectal Cancer

January 23rd, 2013

People who start on Avastin for mCRC can now stay on Avastin after their cancer worsens.

On January 23, 2013, the FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to conti


News in brief

  • People now have the option to continue with Avastin plus a new chemotherapy after their cancer worsens, which may help them live longer than changing to the new chemotherapy alone.
  • This is the third approval for Avastin in mCRC based on improved overall survival in a pivotal study.

Full Prescribing Information including boxed WARNINGS

Read the press release


Supporting Information


Understanding CRC

Colorectal cancer is the third most commonly diagnosed cancer in both men and women in the United States.

Press Release

(January 23, 2013) FDA Approves New Use Of Avastin Plus Chemotherapy For People With Metastatic Colorectal Cancer

BOXED WARNINGS and Additional Important Safety Information

Possible Serious Side Effects

Everyone reacts differently to Avastin therapy. So it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

Most serious side effects (not common, but sometimes fatal):

  • GI perforation— A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Wounds that don't heal— A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding— This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor

Other possible serious side effects

  • Abnormal passage in the body— This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • Severe high blood pressure— Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems— These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion reactions— These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion reactions
  • Severe stroke or heart problems— These may include blood clots, mini-stroke, heart attack, and chest pain. These can sometimes be fatal
  • Nervous system and vision problems— Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Rectal bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone.

Talk to your doctor if you are:

  • Undergoing surgery— Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Pregnant— Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant
  • Planning to become pregnant— Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
  • Breastfeeding— Breastfeeding while on Avastin may harm your baby and is therefore not recommended

If you have any questions about your condition or treatment, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information, including Serious Side Effects, for additional important safety information.