FDA Approves Genentech’s Avastin (Bevacizumab) Plus Chemotherapy as a Treatment for Women With Advanced Ovarian Cancer Following Initial Surgery

– Avastin is now approved for ten distinct uses across six different
types of cancer in the United States –

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
approved Avastin® (bevacizumab) in combination with
chemotherapy (carboplatin and paclitaxel), followed by Avastin as a
single agent, for the treatment of women with advanced (stage III or IV)
ovarian cancer following initial surgical resection.

“Today’s approval is an important advance for women newly diagnosed with
this type of ovarian cancer,” said Sandra Horning, M.D., chief medical
officer and head of Global Product Development. “We’re committed to
advancing medicines in areas of unmet need and this FDA approval of
Avastin plus chemotherapy gives women with advanced ovarian cancer a new
treatment option that has been shown to significantly delay disease
progression or death.”

“This approval represents an important milestone as the first medicine,
other than chemotherapy, for women with advanced ovarian cancer after
their initial surgery,” said David Barley, chief executive officer,
National Ovarian Cancer Coalition (NOCC). “Ovarian cancer is the fifth
leading cause of cancer-related deaths among women in the United States,
and this approval underscores Genentech’s dedication to bringing new
treatment options to women with gynecological cancers.”

The approval for Avastin, in combination with carboplatin and
paclitaxel, followed by Avastin as a single agent, for the treatment of
women with stage III or stage IV epithelial ovarian, fallopian tube, or
primary peritoneal cancer following initial surgical resection, is based
on data from the pivotal Phase III GOG-0218 trial. Women who received
Avastin in combination with chemotherapy, and continued use of Avastin
alone, had a median progression-free survival (PFS) of 18.2 months
compared to 12.0 months in women who received chemotherapy alone
(HR=0.62; 95% CI 0.52 – 0.75, p<0.0001). This PFS benefit was achieved with a fixed-duration treatment (up to 22 cycles of Avastin total). Avastin has boxed warnings for GI perforation, surgery and wound healing complications and hemorrhage.

Avastin is now approved for ten distinct uses across six different types
of cancer in the United States. This indication represents Avastin’s
fourth gynecologic oncology indication in four years, including advanced
cervical cancer and two different forms of ovarian cancer that recurred
after platinum-based chemotherapy.

About the GOG-0218 Study

GOG-0218 (NCT00262847) is a multi-center, randomized, double-blind,
placebo-controlled Phase III study in 1,873 women with previously
untreated stage III or IV epithelial ovarian, primary peritoneal, or
fallopian tube carcinoma who already had surgery to remove as much of
the tumor as possible. Participants were randomized into one of three
treatment arms: chemotherapy alone (carboplatin and paclitaxel), Avastin
(15 mg/kg) plus chemotherapy followed by placebo alone, or Avastin plus
chemotherapy followed by Avastin alone for a total of up to 22 cycles.
The primary endpoint of the study was investigator-assessed PFS and
secondary endpoints included overall survival (OS). The study was
conducted by the Gynecologic Oncology Group (GOG) and initial results
were previously published in the New England Journal of Medicine.

 
GOG-0218 Study Results
Study Group   Avastin with chemotherapyfollowed by Avastin alone

(N=623)

 

Avastin with chemotherapy

(N=625)

 

Chemotherapy alone

(N=625)

Progression-free survival (PFS, primary endpoint)
Median PFS (months)   18.2   12.8   12.0

Hazard ratio (95% CI)1

  0.62 (0.52, 0.75)   0.83 (0.70, 0.98)    
p–value2   < 0.0001   Not significant    
Overall survival (OS, secondary endpoint)3
Median OS (months)   43.8   38.8   40.6
Hazard ratio (95% CI)1   0.89 (0.76, 1.05)   1.06 (0.90, 1.24)    
Safety

Grade 3-4 adverse events occurring more often (≥2%) in the Avastin
with chemotherapy followed by Avastin alone arm or the Avastin
with chemotherapy arm versus the chemotherapy alone arm were
fatigue (9%, 6%, 6%, respectively), high blood pressure (10%, 6%,
2%), decreased platelet count (21%, 20%, 15%) and decreased white
blood cell count (51%, 53%, 50%).

1 Relative to the control arm; stratified hazard ratio

2 Two-sided p-value based on re-randomization test

3 Final overall survival analysis

About Ovarian Cancer

Ovarian cancer causes more deaths among women than any other gynecologic
cancer in the United States. In 2018, more than 22,000 women will be
diagnosed with ovarian cancer in the U.S. and about 14,000 will die from
the disease. About 80% of ovarian cancer cases are found at an advanced
stage, when the cancer has spread beyond the ovaries. Early ovarian
cancer often does not have any symptoms and when symptoms, such as
abdominal swelling, bloating, abdominal pain, difficulty eating or
feeling full quickly and/or frequent urination, are present, they can be
associated with other less serious conditions. Five-year survival rates
worsen dramatically based on stage of diagnosis.

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
  • Ovarian cancer (OC). Avastin, in combination with carboplatin
    and paclitaxel, followed by Avastin alone, is used for the treatment
    of patients with advanced (Stage III or IV) epithelial ovarian,
    fallopian tube, or primary peritoneal cancer following initial surgery.

    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 contact
their 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 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 during and for 6 months after taking
    Avastin

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 and Boxed WARNINGS 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.

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or
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or
Karl Mahler,
011 41 61 687 8503