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Senior Citizen Health & Medicine
FDA Approves First Drug Treatment for Late-Stage
Cervical Cancer
Follows approval earlier this month of first
vaccine to prevent it
June 17, 2006 – The war against cervical cancer – a
deadly disease that primarily strikes older women – has received two big
boosts from the U.S. Food and Drug Administration. This week it approved
a combination of Hycamtin (topotecan hydrochloride) and cisplatin for
use as the first drug treatment for women with late-stage cancer of the
cervix when a physician determines that surgery or radiation therapy are
unlikely to be effective. Early this month the agency approved Gardasil
as the first vaccine developed to prevent cervical cancer.
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The treatment approval includes a new use
for Hycamtin, which was approved in 1996 for treating ovarian cancer and
in 1998 for small cell lung cancer.
Cancer of the cervix occurs most often in women
over the age of 40. In the United States there are an estimated 10,000
new cases of cervical cancer and about 3,700 related deaths each year.
"We are making great strides in the fight against
cervical cancer, a disease that, world wide, is the second most common
cancer in women," said Dr. Andrew von Eschenbach, Acting FDA
Commissioner. "This course of drug therapy is a potentially
life-prolonging option for thousands of women."
The combination of Hycamtin and cisplatin is
specifically indicated for women with Stage IVB (incurable), recurrent,
or persistent cancer of the cervix which spreads to other organs and is
not likely respond to treatment with surgery or radiation.
In clinical trials involving this patient
population, 293 patients were randomized to Hycamtin plus cisplatin or
to cisplatin alone. Most of the participants had received prior
radiation therapy as the standard treatment, while some may have
undergone prior surgery. The combination therapy significantly improved
survival compared to the use of cisplatin alone. Patients on combined
therapy survived (9.4 months), about three months longer than patients
on cisplatin alone (6.5 months).
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Cervical Cancer Statistics |
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From 2000-2003, the median age at
death for cancer of the cervix uteri was 57 years of age.
Approximately 0.0% died under age 20; 5.6% between 20 and 34;
16.7% between 35 and 44; 22.6% between 45 and 54; 18.5% between
55 and 64; 15.3% between 65 and 74; 14.0% between 75 and 84; and
7.3% 85+ years of age.
The age-adjusted death rate was
2.6 per 100,000 women per year. These rates are based on
patients who died in 2000-2003 in the US.
From 2000-2003, the median age at
death for cancer of the cervix uteri was 57 years of age.
Approximately 0.0% died under age 20; 5.6% between 20 and 34;
16.7% between 35 and 44; 22.6% between 45 and 54; 18.5% between
55 and 64; 15.3% between 65 and 74; 14.0% between 75 and 84; and
7.3% 85+ years of age.
National Cancer Institute |
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Hycamtin is associated with a significant risk of
neutropenia (a drop in white blood cell count), a condition which makes
it more difficult for the body to fight infections. Serious side effects
also include thrombocytopenia, a decrease in blood platelets that can
lead to excessive bleeding and anemia. Less serious side effects include
nausea and vomiting. The incidences of neutropenia, anemia, and
thrombocytopenia were significantly increased among patients receiving
the combination treatment compared to those receiving cisplatin alone,
as were nausea and vomiting, mucositis, rash, and liver toxicity.
Hycamtin is manufactured by GlaxoSmithKline,
Research Triangle Park, NC.
FDA Licenses New
Vaccine for Prevention of Cervical Cancer
On June 8, the FDA announced the approval of
Gardasil, the first vaccine developed to prevent cervical cancer,
precancerous genital lesions and genital warts due to human
papillomavirus (HPV) types 6, 11, 16 and 18. The vaccine is approved for
use in females 9-26 years of age. Gardasil was evaluated and approved in
six months under FDA's priority review process--a process for products
with potential to provide significant health benefits.
"Today is an important day for public health and
for women's health, and for our continued fight against serious
life-threatening diseases like cervical cancer," said Alex Azar, Deputy
Secretary, U.S. Department of Health and Human Services (HHS). "HHS is
committed to advancing critical health measures such as the development
of new and promising vaccines to protect and advance the health of all
Americans."
HPV is the most common sexually-transmitted
infection in the United States. The Centers for Disease Control and
Prevention estimates that about 6.2 million Americans become infected
with genital HPV each year and that over half of all sexually active men
and women become infected at some time in their lives. On average,
there are 9,710 new cases of cervical cancer and 3,700 deaths attributed
to it in the United States each year. Worldwide, cervical cancer is the
second most common cancer in women; and is estimated to cause over
470,000 new cases and 233,000 deaths each year.
For most women, the body's own defense system will
clear the virus and infected women do not develop related health
problems. However, some HPV types can cause abnormal cells on the
lining of the cervix that years later can turn into cancer. Other HPV
types can cause genital warts. The vaccine is effective against HPV
types 16 and 18, which cause approximately 70 percent of cervical
cancers and against HPV types 6 and 11, which cause approximately 90
percent of genital warts.
"This vaccine is a significant advance in the
protection of women's health in that it strikes at the infections that
are the root cause of many cervical cancers," said Andrew C. von
Eschenbach, MD, Acting Commissioner of Food and Drugs. "The development
of this vaccine is a product of extraordinary work by scientists as well
as by FDA's review teams to help facilitate the development of very
novel vaccines to address unmet medical needs. This work has resulted
in the approval of a number of new products recently, including
Gardasil, which address significant public health needs."
Gardasil is a recombinant vaccine (contains no live
virus) that is given as three injections over a six-month period.
Immunization with Gardasil is expected to prevent most cases of cervical
cancer due to HPV types included in the vaccine. However, females are
not protected if they have been infected with that HPV type(s) prior to
vaccination, indicating the importance of immunization before potential
exposure to the virus. Also, Gardasil does not protect against less
common HPV types not included in the vaccine, thus routine and regular
pap screening remain critically important to detect precancerous changes
in the cervix to allow treatment before cervical cancer develops.
"This is the first vaccine licensed specifically to
prevent cervical cancer. Its rapid approval underscores FDA's commitment
to help make safe and effective vaccines available as quickly as
possible. Not only have vaccines dramatically reduced the toll of
diseases in infants and children, like polio and measles, but they are
playing an increasing role protecting and improving the lives of
adolescents and adults," said Jesse Goodman, MD, MPH, Director of FDA's
Center for Biologics Evaluation and Research.
Four studies, one in the United States and three
multinational, were conducted in 21,000 women to show how well Gardasil
worked in women between the ages of 16 and 26 by giving them either the
vaccine or placebo. The results showed that in women who had not
already been infected, Gardasil was nearly 100 percent effective in
preventing precancerous cervical lesions, precancerous vaginal and
vulvar lesions, and genital warts caused by infection with the HPV types
against which the vaccine is directed. While the study period was not
long enough for cervical cancer to develop, the prevention of these
cervical precancerous lesions is believed highly likely to result in the
prevention of those cancers.
The studies also evaluated whether the vaccine can
protect women already infected with some HPV types included in the
vaccine from developing diseases related to those viruses. The results
show that the vaccine is only effective when given prior to infection.
Two studies were also performed to measure the
immune response to the vaccine among younger females aged 9-15 years.
Their immune response was as good as that found in 16-26 year olds,
indicating that the vaccine should have similar effectiveness when used
in the 9-15 year age group.
The safety of the vaccine was evaluated in
approximately 11,000 individuals. Most adverse experiences in study
participants who received Gardasil included mild or moderate local
reactions, such as pain or tenderness at the site of injection.
The manufacturer has agreed to conduct several
studies following licensure, including additional studies to further
evaluate general safety and long-term effectiveness. The manufacturer
will also monitor the pregnancy outcomes of women who receive Gardasil
while unknowingly pregnant. Also, the manufacturer has an ongoing
study to evaluate the safety and effectiveness of Gardasil in males.
Gardasil is manufactured by Merck & Co., Inc., of
Whitehouse Station, NJ.
For more information, see:
>>
http://www.fda.gov/cber/products/hpvmer060806.htm
>>
http://www.fda.gov/womens/getthefacts/hpv.html
>> What you need to know about Cervical Cancer –
National Cancer Institute
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