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Senior Citizen Health & Medicine
Herceptin May Reduce Breast Cancer by 50 Percent in
New Use for Post-Surgery Patients
FDA gives go-ahead
after a priority review of trial results
November 17, 2006 The Food and Drug
Administration, after a priority review, approved the expanded use of
Herceptin, a drug made by Genentech Inc., for treatment in combination
with other cancer drugs for HER2 positive breast cancer following a
lumpectomy or mastectomy. It is estimated this new treatment option can
reduce the risk of breast cancer recurrence by 50 percent or more for
these patients predominately senior citizens.
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Related Stories |
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Herceptin with Chemotherapy Improves Survival in
Early Stage Breast Cancer
Dec. 9, 2005 - Pairing the targeted therapy Herceptin with chemotherapy in patients with early stage breast cancer
significantly increases disease-free survival time in women who test
positive for a genetic mutation that results in a particularly
aggressive form of the disease, according to large, international study.
Read more...
Recurrence of Aggressive Breast Cancer Cut in Half
by Herceptin
Drug attacks HER2-positive breast cancer seen in
one-fourth of cases
Oct. 20, 2005 The risk of the reoccurrence of
early-state HER2-positive breast cancer an aggressive form of the
disease found in about one-fourth of cases - can be reduced almost in
half by taking the drug Herceptin (trastuzumab) after standard
chemotherapy treatment. It is certainly good news to older women, who
are the most likely to develop breast cancers - about 3.83% of women 60
to 70. Read more...
New Radiation Therapy May Reduce Breast Cancer
Treatment by Weeks
Proton beam therapy was successful with
four days of treatment
October 31, 2006 National Breast Cancer Awareness
Month ends with good news. A new accelerated approach to radiation
therapy - proton beam therapy has successfully reduced the traditional
time of treatment from six weeks or more to less than a week for women
with early-stage breast cancer, according to a new study released today
in the International Journal for Radiation Oncology-Biology-Physics, the
official journal of ASTRO.
Read more...
Surgery Best for Controlling Breast Cancer in
Elderly Women
By
Becky Ham,
Health Behavior News Service
Jan. 30, 2006 - Although women over age 70 are
rarely offered surgery to treat their breast cancer, a new review of
recent studies suggests surgery works better than hormone therapy to
stop the progression of breast cancer in older women with operable
tumors.
Read more...
Breast Cancer Survivors Have 25 Percent Chance of
Cancer Somewhere Else
International study examines second cancers and
possible causes
Dec. 8, 2005 Women who have suffered from breast
cancer have a 25 percent greater risk than other women of developing a
new cancer somewhere else in their bodies. Researchers who conducted an
international study of over a half-million women with breast cancer also
analyzed the second cancers and possible causes.
Read more...
Breast Cancer Survivor May Develop a Vaccine for the
Disease
 Dr.
Yvonne Paterson's vaccine Lovaxin B now in pre-clinical testing
September 26, 2006 A vaccine for breast cancer
may be developed through the leadership of a breast cancer survivor.
Yvonne Paterson, Ph.D., the scientific founder of Advaxis, Inc., as well
as a Professor of Microbiology at the University of Pennsylvania, and
her team, are working on a suite of new vaccines to treat women with
different types of cancers, including breast cancer.
Read more...
Raloxifene Makes Huge Reduction in Breast Cancer
Risk for Older Women, Especially with Disease in Family
89% reduction with family history of the
disease, 58% without
September 13, 2006 Older women the most likely
to develop breast cancer and in particular those women with a family
history of the disease, found reason for a feeling of relief from the
release of a study showing Raloxifene clearly reduces their risk from
developing invasive breast cancer. Raloxifene, trade name Evista,
is a drug to prevent and treat osteoporosis and has not been approved by the federal Food and Drug Administration as an
agent to prevent breast cancer.
Read more...
Raloxifene Again Found to Deter Breast Cancer in
Older Women, plus Vertebral Fractures
But study finds increased problems of
blood clots and fatal strokes
July 17, 2006
Read more...
Risks Skyrocket for Breast and Ovarian Cancers in
Women with Familial Syndrome
Heredity link is focus for Gynecologic
Cancer Awareness Month
September 12, 2006
Read more...
Cancer Death Risk Continues to Decline Says New
Report
Study of 1975-2003 finds the rate of new
cancers remains stable
September 7, 2006 -
Read more...
S14 Protein Receiving Attention for its Potential to
Treat Beast Cancer
Tumors 'addicted' to S14 and breast cancer
cells die if it is removed
August 22, 2006
Read more...
Older Men Need to Be Aware of Danger from Deadly
Male Breast Cancer
Death rate higher that testicular and prostate
cancer combined
 October
12, 2006 This is national Breast Cancer Awareness Month and most are
familiar with the pink ribbon worn to trigger cancer awareness. Adding a
small blue ribbon to the symbol may be a good idea, because it may help
save the lives of men with breast cancer nearly 500 men in the U.S.
will die from it this year.
Read more...
Breast Cancer Survival Gains Due to Smaller Tumors
Womens Fear of Heart Disease Doubles But Breast
Cancer Still No. 1 Fear
Low-Dose Aspirin Does Not Prevent Cancer in Older,
Healthy Women
Breast Cancer Survival Gains Due to Smaller Tumors
Aug. 8, 2005
Womens Fear of Heart Disease Doubles But Breast Cancer Still
No. 1
July 7, 2005
Apple A Day Keeps Breast Cancer Away
March 1, 2005
New Breast Implant Claims More Natural Look, Fewer
Complications but Waits FDA Hearing - Oct. 17, 2005
New Website Offers Professional Advice on Breast
Implants - March 7, 2006
Cancer Study Says Prostate Most Common for Men, Breast for Women
...
New Cancer Report Sees Declining Deaths,
Stable Incident Rates
Dec. 23, 2005 The nation is making progress
toward major cancer-related Healthy People 2010 targets, according to
the new Cancer Trends Progress Report 2005. The death rates continue to
decline for the four most common cancers - prostate, breast, lung, and
colorectal, as well as for all cancers combined. And, the rate of cancer
occurrences has been relatively stable since the mid 1990s.
Read more...
Read more
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"The results of the joint analysis show that, for
women with early-stage HER2-positive breast cancer, the addition of
Herceptin to chemotherapy reduces the relative risk of breast cancer
recurrence by approximately half, which translates into fewer women
dying from one of the most aggressive types of breast cancer," said
Edward Romond, M.D., Professor of Medicine, Division of
Hematology/Oncology at the University of Kentucky.
"This is the largest improvement in outcome for any
group of women with breast cancer in 25 years."
"Today's approval is wonderful news for women with
early-stage HER2- positive breast cancer and another significant
milestone in the Herceptin story," said Fran Visco, president of the
National Breast Cancer Coalition.
"Thanks to the thousands of breast cancer patients,
clinical investigators, the FDA, Genentech and advocates, who have all
played critical roles in Herceptin's development, we now have a
treatment option that represents a major advance for women with
HER2-positive breast cancer before the disease has metastasized. We look
forward to continuing our collaboration with Genentech on future
Herceptin research."
Herceptin is a targeted therapy against the HER2
protein on cancer cells. When an excessive amount of HER2 protein is
present, it causes cancer cells to grow more rapidly and standard
chemotherapy may be less effective.
In 1998, FDA approved Herceptin for the treatment
of metastatic breast cancer (cancer that has spread to other sites in
the body). Today's approval expands its use to women with cancer only in
the breast or lymph nodes which has been removed with surgery. Herceptin
should only be prescribed for women diagnosed with HER2 positive breast
cancer.
"This is especially good news for women who have
breast cancer caused by excessive amounts of the HER-2 protein because
this cancer typically has a poor prognosis," said Dr. Steven Galson,
Director for FDA's Center for Drug Evaluation and Research.
The drug-maker, Genentech, Inc., said the
FDAapproved Herceptin (Trastuzumab), as part of a treatment regimen
containing doxorubicin, cyclophosphamide, and paclitaxel, for the
adjuvant treatment of HER2-positive node-positive breast cancer.
Adjuvant therapy is given to women with early-stage
(localized) breast cancer who have had initial treatment - surgery with
or without radiation therapy - with the goal of reducing the risk of
cancer recurrence and/or the occurrence of metastatic disease.
The two studies leading to this new approved
indication were conducted by the National Cancer Institute-sponsored
Cooperative Groups, a multicenter clinical trials group. Patients in
both trials received standard chemotherapy after surgery for breast
cancer; approximately half the patients were also given Herceptin. The
results from both trials, which included information on nearly 4,000
women, were combined and analyzed in 2005.
Due to positive results, the National Cancer
Institute, a part of the National Institutes of Health, ended the
studies early. The results showed that women who received Herceptin
combined with chemotherapy had fewer relapses (return of breast cancer)
for up to three years after surgery. The estimated three-year
disease-free rates were 87 percent in women receiving Herceptin and
chemotherapy and 75 percent in those receiving chemotherapy alone.
It is too soon to know whether Herceptin combined
with chemotherapy will increase the cure rate or lower the risk of death
from breast cancer, according to the FDA.
"Our work with Herceptin exemplifies our commitment
to developing the right drug for the right patient. We designed
Herceptin for the approximately 25 percent of women whose breast cancers
overexpress HER2 because we believed that we could make a significant
impact for these patients battling a very aggressive, difficult-to-treat
disease," said Susan Desmond-Hellmann, M.D., M.P.H., Genentech's
president, product development.
"These adjuvant studies showed that, in women with
HER2-positive lymph node-positive breast cancer, Herceptin reduces the
risk of developing metastatic disease, which could benefit thousands of
lives worldwide each year."
"This approval also highlights a first step in a
major initiative to conduct studies of Genentech targeted therapies in
earlier stages of disease where they have the potential to have the
greatest impact," added Desmond- Hellmann.
In the United States there are an estimated 212,
920 new cases of breast cancer and about 40,970 related deaths each
year. Approximately 25 percent of women with breast cancer will have
tumors that produce excessive amounts of HER2 protein.
The most serious side effect of Herceptin is heart
failure (weakening of the heart muscle) that requires medical treatment.
Due to the risk of heart disease, only certain patients should receive
the drug, including:
Only patients whose tumors are HER2 Positive
Patients who do not have heart failure or weak
heart muscle (cardiomyopathy). Patients must be screened for heart
function before beginning and during Herceptin treatment.
Less common but serious side effects include
infusion reactions (chills, fever, shortness of breath) that rarely are
accompanied by lung problems, low white blood counts, and low red blood
cell counts.
Herceptin (trastuzumab) is manufactured by
Genentech San Francisco, CA.
More About
Herceptin Genentech statement
Herceptin is a targeted therapeutic antibody
treatment for women who have tumors that overexpress the human epidermal
growth factor receptor 2 (HER2) protein. HER2-positive breast cancer is
an especially aggressive form of the disease that affects approximately
one-fourth of women with breast cancer. Research has shown that women
with HER2-positive breast cancer have a greater likelihood of
recurrence, poorer prognosis and decreased survival compared to women
with HER2-negative breast cancer. Special testing is required to
identify women who have HER2-positive breast cancer and who may be
candidates for treatment with Herceptin.
Herceptin is the only targeted biologic therapy
approved for treatment of HER2-positive breast cancer in the adjuvant
and metastatic settings. Herceptin first received FDA approval in
September 1998 for use in women with metastatic breast cancer. In this
setting, it is indicated for treatment of patients both as a first-line
therapy in combination with paclitaxel and as a single agent in second-
and third-line therapy.
In clinical trials of HER2-positive metastatic
breast cancer patients, Herceptin in combination with chemotherapy (paclitaxel)
was the first anti- HER2 agent to demonstrate an improvement in survival
in a Phase III trial. In December 2001, Genentech received FDA approval
to include, in the product label, data that showed an improved median
overall survival for women with HER2-positive metastatic breast cancer
treated initially with Herceptin and chemotherapy, compared to
chemotherapy alone (median 25.1 months compared to 20.3 months).
Herceptin Safety Profile
Herceptin administration can result in left
ventricular dysfunction and congestive heart failure (CHF). The
incidence and severity of left ventricular cardiac dysfunction/CHF were
highest in patients who received Herceptin concurrently with
anthracycline-containing chemotherapy regimens.
Herceptin should be discontinued in patients
receiving adjuvant therapy for breast cancer who develop a clinically
significant decrease in left ventricular function. In patients with
metastatic breast cancer who develop a clinically significant decrease
in left ventricular function, discontinuation of Herceptin should
strongly be considered.
Serious infusion reactions and pulmonary toxicity
have occurred; rarely these have been fatal. Discontinuation of
Herceptin should be strongly considered for infusion reactions
manifesting as anaphylaxis, angioedema, pneumonitis, or acute
respiratory distress syndrome.
Exacerbation of chemotherapy-induced neutropenia
has also occurred.
The most common adverse reactions associated with
Herceptin use were fever, nausea, vomiting, infusion reactions,
diarrhea, infections, increased cough, headache, fatigue, dyspnea
(shortness of breath), rash, neutropenia (decrease in the number of
neutrophils, a type of white blood cell), anemia, and myalgia (muscle
pain).
About Breast Cancer
According to the American Cancer Society, 212,920
women in the United States will be diagnosed with breast cancer in 2006,
and 40,970 will die from the disease. Excluding skin cancer, breast
cancer is the most common form of cancer among women and the
second-leading cancer killer among women, after lung cancer. The chance
of a woman having invasive breast cancer some time during her life is
about 1 in 8. The chance of dying from breast cancer is about 1 in 33.
Breast cancer death rates are going down. This decline is probably the
result of finding the cancer earlier and improved treatment.
Genentech's Commitment to Patient Access
(Company statement)
Genentech is committed to assisting eligible
patients in accessing our therapies for approved indications, regardless
of their ability to pay. Although Genentech's products are covered by
most government and private insurance, Genentech established the
Genentech(R) Access to Care Foundation (GATCF) in 1990 for its marketed
products. GATCF donates product to eligible patients in the United
States who are uninsured or deemed uninsured due to payor denial, except
for Pulmozyme(R) (dornase alfa, recombinant), which is covered by the
Genentech Endowment for Cystic Fibrosis. In 2005 alone, GATCF supported
over 18,000 patients by providing approximately $200 million of free
product. In addition, Genentech recently doubled to $50 million its
donation to several independent public charities that provide financial
assistance to eligible patients who cannot access needed medical
treatment due to co-pay costs. To learn more about potential financial
assistance options, patients can speak with an Alternative Funding
Specialist from Genentech's Single Point of Contact (SPOC) group by
calling 866-724-9394 or visiting
http://www.spoconline.com/ .
About Genentech BioOncology (Company statement)
Genentech is committed to changing the way cancer
is treated by establishing a broad oncology portfolio of innovative,
targeted therapies with the goal of improving patients' lives. The
company is the leading provider of anti-tumor therapeutics in the United
States. Genentech is conducting clinical development programs for
Rituxan(R) (Rituximab), Herceptin(R) (Trastuzumab), Avastin(R) (bevacizumab),
and Tarceva(R) (erlotinib), and markets all four products in the United
States, either alone (Avastin and Herceptin) or with Biogen Idec Inc. (Rituxan)
or OSI Pharmaceuticals, Inc. (Tarceva). For sale outside of the United
States, Genentech has licensed Rituxan, Herceptin, and Avastin to Roche,
and OSI Pharmaceuticals has licensed Tarceva to Roche.
The company has a robust pipeline of potential
oncology therapies with a focus on four key areas: angiogenesis,
apoptosis (i.e., programmed cell death), the HER pathway, and B-cell
biology. An investigational antibody directed at the HER pathway is
currently in Phase II trials. In early development, are a small molecule
directed at the hedgehog pathway and an investigational agent targeting
apoptosis.
Founded 30 years ago, Genentech is a leading
biotechnology company that discovers, develops, manufactures and
commercializes biotherapeutics for significant unmet medical needs. A
considerable number of the currently approved biotechnology products
originated from or are based on Genentech science. Genentech
manufactures and commercializes multiple biotechnology products and
licenses several additional products to other companies. The company has
headquarters in South San Francisco, Calif., and is listed on the New
York Stock Exchange under the symbol DNA. For additional information
about the company, please visit
http://www.gene.com/ .
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