Dako - HercepTest Stomach Cancer Drug

By Andrea: http://nursingoncologyjob.com

Dako has received approval from the U.S. Food and Drug Administration (FDA) to expand
the intended use for HercepTest(TM) and HER2 FISH pharmDx(TM) Kit to include patients
with metastatic gastric or gastroesophageal junction adenocarcinoma (stomach cancer).
Dako's diagnostic tests are indicated as an aid in the assessment of patients for whom
Herceptin (trastuzumab) treatment is being considered. The FDA has simultaneously
approved the use of Herceptin in combination with chemotherapy for HER2-positive,
metastatic stomach cancer or cancer of the gastroesophageal junction. Results from a
recent clinical study indicate that patients with HER2-positive metastatic stomach
cancer live longer when treated with Herceptin in combination with chemotherapy,
compared to chemotherapy alone.

Sunil S. Badve, MB, BS, FRCPath, professor at the Indiana University, Department of
Pathology & Laboratory Medicine (USA) and diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, states:

"Dako's HercepTest(TM) and HER2 FISH pharmDx(TM)Kit will be a great advance to the
identification of patients with metastatic stomach cancer who are appropriate for HER2
targeted therapy with Herceptin. The diagnostic tests can identify the group of patients having HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma, and are appropriate candidates for receiving the right combination of targeted treatment and chemotherapy. With these diagnostic kits we now have tools to aid in the selection of a therapy for approx. 22% of the estimated 21,130 Americans who are diagnosed with stomach cancer each year."

The FDA approval of Dako's HercepTest(TM) and HER2 FISH pharmDx(TM) Kit for use in
stomach cancer patients in the United States is based on the positive results of an
international Phase III study (ToGA).In the screening phase for assessing HER2-status,
the study involved more than 3,700 patients at 122 sites in 24 countries. The
FDA-approved dataset (N=594) showed that treatment with Herceptin® in combination with
chemotherapy in patients with metastatic HER2-positive stomach cancer found by the use
of Dako's diagnostic tests significantly prolongs the lives of patients with this
aggressive cancer.

"The FDA approval underlines our commitment to develop high quality diagnostic tests to
identify the right cancer patients for specific cancer therapy. We have seen how Dako's
HercepTest(TM) and HER2 FISH pharmDx(TM) Kit combined with Herceptin® treatment have
revolutionized the field of breast cancer. It is our hope that these diagnostic kits
will help patients with HER2-positive stomach cancer just as much," says Lars Holmkvist,CEO of Dako.

Stomach cancer is the second most common cause of cancer-related deaths globally with
over 1,000,000 new cases diagnosed each year. An estimated 21,130 Americans were
diagnosed with stomach cancer and more than 10,600 Americans died from the disease in
2009, according to the American Cancer Society (ACS). More than 64,000 Americans are
currently living with the disease. Early diagnosis is challenging because most patients
do not show symptoms in the early stage. Approximately one in five of all stomach tumors are HER2-positive.

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