FDA APPROVES HERCEPTIN(R) (TRASTUZUMAB) FOR THE ADJUVANT TREATMENT OF HER2-POSITIVE NODE-POSITIVE BREAST CANCER
17 Novembro 2006 - 6:59PM
PR Newswire (US)
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http://www.prnewswire.com/broadcast/23534/consumer.html NEW YORK,
November 17 /PRNewswire/ -- THIS IS A MULTIVU REPORT BROUGHT TO YOU
BY GENENTECH. THE FDA HAS JUST APPROVED HERCEPTIN, AS PART OF A
TREATMENT REGIMEN CONTAINING DOXORUBICIN, CYCLOPHOSPHAMIDE, AND
PACLITAXEL, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH
HER2-POSITIVE NODE-POSITIVE BREAST CANCER. DR. EDWARD H. ROMOND IS
PROFESSOR OF MEDICINE, DIVISION OF HEMATOLOGY AND ONCOLOGY AT THE
UNIVERSITY OF KENTUCKY: "I think that the FDA approval for
Herceptin for women with early stage her2-positive breast cancer is
an extremely important and major step forward for women who have
this disease." HER2-POSITIVE BREAST CANCER IS PARTICULARLY
AGGRESSIVE AND OCCURS IN APPROXIMATELY 25 PERCENT OF WOMEN WITH
BREAST CANCER. HERCEPTIN ADMINISTRATION CAN RESULT IN LEFT
VENTRICULAR DYSFUNCTION AND CONGESTIVE HEART FAILURE. SERIOUS
INFUSION REACTIONS AND PULMONARY TOXICITY HAVE OCCURRED; RARELY
THESE HAVE BEEN FATAL. FOR MORE INFORMATION ON HERCEPTIN OR
HER2-POSITIVE BREAST CANCER, PATIENTS SHOULD TALK TO THEIR DOCTOR
OR VISIT HERCEPTIN.COM. I'M DANIELLE ADDAIR. HERCEPTIN SAFETY
INFORMATION : 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, rash, neutropenia, anemia, and myalgia.
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