FDA Grants Genentech’s Avastin Full Approval for Most Aggressive Form of Brain Cancer
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration
(FDA) has granted full approval for Avastin® (bevacizumab) for the treatment of adults with glioblastoma that progressed
following prior therapy (referred to as recurrent disease). Avastin was previously granted provisional approval in this setting
under the FDA's accelerated approval program.
“Glioblastoma is the most common and aggressive form of brain cancer and can be very difficult to treat,” said Sandra Horning,
M.D., chief medical officer and head of Global Product Development. “Delaying disease progression and reducing the need for
corticosteroids over the course of treatment are considered important goals for those impacted by this devastating disease where
patients have limited treatment options.”
This conversion to full approval was based on the totality of evidence of Avastin in glioblastoma, including data from the Phase
III EORTC 26101 study. Avastin is now approved in the United States for nine distinct uses across six different types of
cancer.
About the EORTC 26101 Study
EORTC 26101 is an independent Phase III, multicenter, randomized, open-label trial, conducted by the European Organization for
Research and Treatment of Cancer (EORTC), that evaluated the addition of Avastin to lomustine chemotherapy in 432 patients with
previously treated glioblastoma. The primary endpoint of the study was overall survival (OS), and progression-free survival (PFS)
as assessed by investigator and overall response rate (ORR) were key secondary endpoints. Results showed the following:
- There was no significant increase in OS with Avastin-based treatment (HR=0.91, p=0.4578).
- As the primary endpoint was not met, all secondary endpoints should be considered descriptive
only.
- Avastin-based treatment increased the time to disease progression or death compared to chemotherapy
alone (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95% CI: 0.41-0.64).
- Among people taking corticosteroids at baseline (50 percent), more people were able to completely
stop intake of corticosteroids while on treatment in the Avastin arm compared to the control arm (23 percent vs. 12
percent).
- In the Avastin with lomustine arm, 22 percent of people discontinued treatment due to adverse
reactions compared with 10 percent of people in the lomustine arm.
- Adverse events were consistent with those seen in previous trials of Avastin across tumor types for
approved indications.
About Glioblastoma
Glioma (cancer of the glial cells) is the most common type of malignant primary brain tumor (a tumor that originates in the
brain), and represents nearly one-fourth of all primary brain tumors and three-fourths of all malignant tumors. Glioblastoma (or
glioblastoma multiforme) is the most common and the most aggressive type of glioma, accounting for more than half of all gliomas.
It is estimated that more than 12,300 people will be diagnosed with glioblastoma in the United States in 2017.
About Genentech Access Solutions
Access Solutions is part of Genentech’s commitment to helping people access the Genentech medicines they are prescribed,
regardless of their ability to pay. The team of in-house specialists at Access Solutions is dedicated to helping people navigate
the access and reimbursement process, and to providing assistance to eligible patients in the United States who are uninsured or
cannot afford the out-of-pocket costs for their medicine. To date, the team has helped more than 1.5 million patients access the
medicines they need. Please contact Access Solutions (866) 4ACCESS/(866) 422-2377 or visit http://www.Genentech-Access.com for more information.
About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to
specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the
lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere
with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells.
The tumor blood supply is thought to be critical to a tumor's ability to grow and spread in the body (metastasize).
Avastin Indications:
-
Metastatic colorectal cancer (mCRC) for first- or second-line treatment in combination with intravenous
5-fluorouracil–based chemotherapy. It is also approved to treat mCRC for second-line treatment when used with
fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line
treatment that includes Avastin.
- Avastin is not approved for use after the primary treatment of colon cancer that has not spread
to other parts of the body.
- Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin
and paclitaxel in people who have not received chemotherapy for their advanced disease.
- Metastatic kidney cancer (mRCC) when used with interferon alfa.
- Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment
(recurrent or rGBM).
- Advanced cervical cancer (CC) in combination with paclitaxel and cisplatin or paclitaxel and
topotecan is approved to treat persistent, recurrent, or metastatic cancer of the cervix.
Recurrent ovarian cancer (rOC). Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or
topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer
(prOC) in women who received no more than two prior chemotherapy treatments. Avastin, either in combination
with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of
patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC).
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. Their doctor will stop treatment if any serious side effects occur.
Patients should talk to their doctor 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 the stomach or intestine.
Symptoms include pain in the 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 a patient has recently coughed up blood or
had serious bleeding, they should be sure to tell their 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. The patient’s doctor or nurse will monitor for signs of infusion reactions
- Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack,
chest pain, and the heart may become too weak to pump blood to other parts of the 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
- Rectal bleeding
- Back pain
- Headache
- Taste change
- Dry skin
- Inflammation of the skin
- Inflammation of the nose
- Watery eyes
Avastin is not for everyone
Patients should talk to their doctor if they 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 they are pregnant. Data have shown that Avastin may harm a woman’s unborn
baby. Birth control should be used while patients are on Avastin. If Avastin is stopped, patients 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 the baby and is therefore not
recommended
Patients should talk with their doctor if they have any questions about their condition or treatment.
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch . Report side effects to Genentech at (888) 835-2555.
For full Prescribing Information on Avastin please visit http://www.avastin.com .
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and
commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche
Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
Genentech
Media Contact:
Meghan Cox, 650-467-6800
or
Advocacy Contact:
Nicole Martin, 650-826-9223
or
Investor Contacts:
Loren Kalm, 650-225-3217
Karl Mahler, 011 41 61 687 8503
View source version on businesswire.com: http://www.businesswire.com/news/home/20171205006443/en/