|[July 15, 2014]
FDA Grants Genentech's Avastin Priority Review for Certain Types of Cervical Cancer
SOUTH SAN FRANCISCO, Calif. --(Business Wire)--
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY),
today announced that the U.S. Food and Drug Administration (FDA) has
accepted the company's supplemental Biologics License Application (sBLA)
and granted Priority Review for Avastin® (bevacizumab) plus
chemotherapy for the treatment of women with persistent, recurrent or
metastatic cervical cancer.
"This regulatory application for Avastin is important because
chemotherapy is the only approved treatment for women with metastatic,
recurrent or persistent cervical cancer," said Sandra Horning, M.D.,
chief medical officer and head of Global Product Development. "Treatment
with Avastin plus chemotherapy may help women with these conditions live
longer than chemotherapy alone, and we look forward to working with the
FDA on potentially making this medicine available to patients."
The designation of Priority Review status is granted to medicines that
the FDA believes have the potential to provide "significant improvements
in the safety or effectiveness of the treatment, diagnosis, or
prevention of serious conditions when compared to standard
applications." The sBLA for Avastin plus chemotherapy in persistent,
recurrent or metastatic cervical cancer is based on data from the
Phase III GOG-0240 trial with an FDA action date of October 24, 2014.
About the GOG-0240 Study
GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored
Phase III study which assessed the efficacy and safety profile of
Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and
topotecan) in women with persistent, recurrent or metastatic cervical
cancer. Study data from 452 women showed:
The study met its primary endpoint of improving overall survival (OS)
with a statistically significant 29 percent reduction in the risk of
death for women who received Avastin plus chemotherapy compared to
those who received chemotherapy alone (median OS: 17.0 months vs. 13.3
months; Hazard Ratio (HR)=0.71, p=0.004).
Women in the Avastin plus chemotherapy arm also lived longer without
disease worsening (progression free survival, PFS) compared to those
who received chemotherapy alone (median PFS: 8.2 months vs. 5.9
months; HR=0.67, p=0.002).
Hypertension (high blood pressure) of Grade 2 or higher was
significantly more common with Avastin-containing regimens (25 percent
vs. 2 percent), but no patients discontinued Avastin because of
hypertension. Gastrointestinal or genitourinary fistulas (abnormal
passage from one part of the body to another) of Grade 3 or higher
were significantly increased with the Avastin-containing regimens (6
percent vs. 0 percent), as were thromboembolic events (blood clots) of
Grade 3 or higher (8 percent vs. 1 percent).
There was no increase in treatment-related deaths in the Avastin plus
chemotherapy arm as compared to the chemotherapy alone arm.
About Cervical Cancer
It is estimated that more than 12,000 new cases of cervical cancer will
be diagnosed in the United States in 2014 and about 4,000 women will die
from the disease. There is a dramatic difference in survival rates
between early and advanced cervical cancer. At least nine out of 10
women will live for five years following diagnosis of early stage
disease but the survival rate drops to below one in six women when the
disease is metastatic.
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 knwn 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 U.S. Indications:
Avastin is approved for first- and second-line treatment of metastatic
colorectal cancer in combination with intravenous 5-FU-based
chemotherapy. Avastin, in combination with fluropyrimidine-irinotecan or
fluoropyrimidine-oxaliplatin based chemotherapy, is indicated for the
second-line treatment of patients with metastatic colorectal cancer who
have progressed on a first-line Avastin-containing regimen. Avastin is
not indicated for adjuvant treatment of colon cancer.
Avastin is approved for first-line treatment of unresectable, locally
advanced, recurrent or metastatic, non-squamous, non-small cell lung
cancer in combination with carboplatin and paclitaxel, and metastatic
renal cell carcinoma in combination with interferon alfa.
BOXED WARNINGS and Additional Important Safety Information
People receiving Avastin may experience side effects. In clinical
trials, some people treated with Avastin experienced serious and
sometimes fatal side effects, including:
Gastrointestinal (GI) perforation: Treatment with Avastin can
result in the development of a serious side effect called GI
perforation, which is the development of a hole in the stomach, small
intestine, or large intestine. In clinical trials, this event occurred
in more people who received Avastin than in the comparison group (2.4
percent to 0.3 percent). In some cases, GI perforation resulted in
fatality. Avastin therapy should be permanently stopped if GI
Surgery and wound healing problems: Treatment with Avastin can
lead to slow or incomplete wound healing (for example, when a surgical
incision has trouble healing or staying closed). In some cases, this
event resulted in fatality. Surgery and wound healing problems occurred
more often in people who received Avastin than in the comparison group.
In a controlled clinical trial, in patients with metastatic colorectal
cancer who had surgery during the course of treatment, the incidence of
wound healing complications, including serious and fatal complications,
was 15 percent for patients who received Avastin and four percent for
patients who did not receive Avastin.
Avastin therapy should not be started for at least 28 days after surgery
and until the surgical wound is fully healed. The length of time between
stopping Avastin and having voluntary surgery without the risk of wound
healing problems following surgery has not been determined. Treatment
with Avastin should be stopped at least 28 days before voluntary surgery
and in people with wound healing problems following surgery that require
medical treatment. Treatment with Avastin should be stopped in patients
with slow or incomplete wound healing.
Severe bleeding: Treatment with Avastin can result in serious or
fatal bleeding, including coughing up blood, bleeding in the stomach,
vomiting of blood, bleeding in the brain, nosebleeds and vaginal
bleeding. These events occurred up to five times more often in people
who received Avastin compared to patients who received only
chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people
who received Avastin experienced severe to fatal bleeding. People who
have recently coughed up blood (greater than or equal to a half teaspoon
of red blood) or have serious bleeding should not receive Avastin.
Treatment with Avastin should be permanently stopped if serious bleeding
In clinical trials for different cancer types, there were additional
serious and sometimes fatal side effects that occurred in more people
who received Avastin than in those in the comparison group. The
formation of an abnormal passage from parts of the body to another part
(non-GI fistula formation) was seen in 0.3 percent or less of people.
Severe to life-threatening stroke or heart problems were seen in 2.6
percent of people. Too much protein in the urine that led to kidney
problems was seen in less than one percent of people. Additional serious
side effects that occurred in more people who received Avastin than
those in the comparison group included severe to life-threatening high
blood pressure, which was seen in five percent to 18 percent of people,
and nervous system and vision disturbances (reversible posterior
leukoencephalopathy syndrome), which was seen in less than 0.1 percent
of people. Infusion reactions with the first dose of Avastin were
uncommon and occurred in less than three percent of people, and severe
reactions occurred in 0.2 percent of people. Avastin can cause fertility
issues for women. Avastin could cause a woman's ovaries to stop working
and may impair her ability to have children.
Common side effects that occurred in more than 10 percent of people who
received Avastin for different cancer types, and at least twice the rate
of the comparison group, were nosebleeds, headache, high blood pressure,
inflammation of the nose, too much protein in the urine, taste change,
dry skin, rectal bleeding, tear production disorder, back pain, and
inflammation of the skin (exfoliative dermatitis). Across all trials,
treatment with Avastin was permanently stopped in 8.4 percent to 21
percent of people because of side effects.
Patients who are pregnant or thinking of becoming pregnant should talk
with their doctor about the potential risk of loss of the pregnancy or
the potential risk of Avastin to the fetus during and following Avastin
therapy, and the need to continue an effective birth control method for
at least six months following the last dose of Avastin.
Women should be advised to discontinue nursing or discontinue treatment
with Avastin, taking into account the importance of Avastin to the
Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch.
Patients and caregivers may also report side effects to Genentech at
For full Prescribing Information and Boxed WARNINGS on Avastin, please
Founded more than 35 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.
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