FDA Approves Genentech Medicine for Women with Platinum-Resistant Recurrent Ovarian Cancer

November 14th, 2014

On November 14, 2014, the FDA approved Avastin^® (bevacizumab) in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens.

News in brief

• Women with a specific type of platinum-resistant ovarian cancer now have the option of Avastin in combination with chemotherapy
• In a Phase III trial, Avastin plus chemotherapy reduced the risk of disease worsening or death (progression-free survival or PFS) by 62 percent compared to women who received chemotherapy alone
• Avastin plus chemotherapy is the first treatment option for women with this type of ovarian cancer in more than 15 years
• Avastin is approved in the United States to treat six distinct tumor types

Supporting Information

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.

• GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
• 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
• 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
• 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-related reactions. These were uncommon with the first dose (less than 3% of patients). 0.4% of patients had severe reactions. Infusion-related reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, serious allergic reactions, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion-related reactions
• Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). 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
• 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 or think you are 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, therefore, women should not breastfeed during and for 6 months after taking Avastin

For more information about your treatment or condition, 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.