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A Recently Approved New Indication May Allow More Breast-Cancer Patients to Benefit from Herceptin Therapy
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(OPEN):
GENENTECH RECENTLY RECEIVED APPROVAL FROM THE U-S FOOD
AND DRUG ADMINISTRATION FOR AN ADDITIONAL USE OF HERCEPTIN--ALSO
KNOWN AS TRASTUZUMAB--FOR THE ADJUVANT TREATMENT OF EARLY-STAGE,
"HER-TWO"-POSITIVE BREAST CANCER--AN AGGRESSIVE FORM OF THE DISEASE.
ONE OF THE NEW ADJUVANT INDICATIONS OF HERCEPTIN IS PART OF A
NON-ANTHRACYCLINE CHEMOTHERAPY REGIMEN CONSISTING OF HERCEPTIN,
TAXOTERE, AND CARBOPLATIN. ADJUVANT THERAPY IS GIVEN TO WOMEN WITH
EARLY-STAGE BREAST CANCER WHO HAVE HAD INITIAL TREATMENT OF SURGERY,
WITH THE GOAL OF REDUCING THE RELATIVE RISK OF CANCER COMING BACK.
ONCOLOGIST, DOCTOR STEPHEN MALAMUD...
(MALAMUD):
"HERCEPTIN HAS CHANGED THE COURSE OF
'HER-TWO'-POSITIVE DISEASE SINCE ITS INITIAL APPROVAL, IN 19-98.
THIS NEW INDICATION--BASED ON THE 'B-C-I-R-G DOUBLE-O-SIX' TRIAL--OFFERS
A LOWERED RELATIVE RISK OF A DISEASE RECURRENCE, AS COMPARED TO
CHEMOTHERAPY ALONE--AND A REDUCTION IN CARDIAC RISK, VERSUS THE
HERCEPTIN-BASED ANTHRACYCLINE REGIMEN--WHICH MAY POTENTIALLY ALLOW MORE
PATIENTS TO BENEFIT FROM HERCEPTIN THERAPY."
(CLOSE):
FOR ADDITIONAL INFORMATION, VISIT
W-W-W-DOT-"HERCEPTIN"-DOT-COM; THAT'S "H-E-R-C-E-P-T-I-N"-DOT-COM.
-- Fair Balance --
Who is Herceptin for?
Herceptin is approved for the adjuvant treatment of HER2-overexpressing, node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer. A high-risk feature is ER/PR-positive breast cancer with one of the following: age less than 35 years; tumor greater than two centimeters; or tumor grade two to three. Herceptin can be used several different ways: as part of a treatment regimen including doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline-based therapy. Herceptin, in combination with paclitaxel, is approved for the first-line treatment of HER2-overexpressing metastatic breast cancer. Herceptin, as a single agent, is approved for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
What important safety information should you know about Herceptin?
Herceptin treatment can result in heart problems--including those without symptoms (reduced heart function), and those with symptoms (congestive heart failure). Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported. Worsening of low white-blood-cell counts associated with chemotherapy has also occurred. The most-common side effects associated with Herceptin were: fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white- and red-blood cells, and muscle pain. Because everyone is different, it is not possible to predict what side effects any one person will have. If you have questions or concerns about side effects, talk to your doctor. For full prescribing information--including boxed warnings and important safety information for Herceptin--please call 800-821-8590 or visit www.herceptin.com.
