FDA Approves Medicine for Women with Platinum-Sensitive Recurrent Ovarian Cancer
December 6th, 2016
On December 6, the FDA approved Avastin® (bevacizumab), either in combination with carboplatin and paclitaxel or carboplatin and gemcitabine chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
News in brief
- Avastin plus chemotherapy for platinum-sensitive recurrent ovarian cancer approved today based on results from two large Phase III studies, GOG-0213 and OCEANS
- Ovarian cancer causes more deaths than any other gynecologic cancer in the United States1
- Women are said to have a ‘platinum-sensitive’ form of the disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy 2
- In the United States, Avastin is now approved for nine distinct uses across six different types of 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, 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
- Rectal bleeding
- Back pain
- 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 and is therefore not recommended during and for 6 months after taking Avastin.
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.