Healthcare Industry News:  fluoropyrimidine 

Diagnostics FDA Oncology

 News Release - October 4, 2006

Dako Receives FDA Approval for Use of EGFR pharmDx(TM) With Vectibix(TM)

CARPINTERIA, Calif., Oct. 4 (HSMN NewsFeed) -- Dako, the leading provider of pharmDx(TM) cancer diagnostic tests, has received approval from the U.S. Food and Drug Administration for its EGFR pharmDx(TM) kit, to be used to assess patient eligibility for treatment with Vectibix(TM).

FDA approval of EGFR pharmDx(TM) for this second indicated use was granted simultaneously with approval for Vectibix(TM) (panitumumab), manufactured by Amgen. Vectibix(TM) is indicated for treatment of patients with EGFR-expressing colorectal cancer, the third most common cancer and leading cause of cancer deaths in the United States.

EGFR pharmDx(TM) was approved by the FDA in 2004 as an aid in identifying colorectal cancer patients eligible for treatment with ERBITUX® (Cetuximab), manufactured by ImClone. Today Dako's EGFR pharmDx(TM) kit remains the only FDA-approved test currently available for detection of EGFR protein expression. Colorectal cancer patients enrolled in clinical studies using Vectibix(TM) were tested for immunohistochemical evidence of EGFR expression with this kit.

"Dako is committed to providing the most reliable and accurate diagnostic tests that can enable our pharmaceutical partners to introduce new cancer therapies," said Dennis Chenoweth, Dako's corporate vice president of business development. "We are very pleased to have played a role in the introduction of this new drug that will benefit so many cancer patients around the world."

Vectibix(TM) is indicated for the treatment of patients with EGFR-expressing metastatic colorectal cancer, who have disease progression, on or following fluoropyrimidine, oxaliplatin and irinotecan-containing regimens, according to the FDA. The agency approved the therapy on the basis of the results of a randomized, controlled clinical trial of 463 patients. The approval was part of an accelerated approval program, under which drugs for serious and life-threatening diseases can be made available earlier in the development process if a promising effect of the drug is observed.

Dako A/S is a leading provider of systems solutions for cancer diagnostics and cell analysis. Hospitals, clinical and research laboratories worldwide use Dako products for precise diagnoses and to help determine the most effective treatment for patients suffering from cancer or other serious diseases. Dako is privately owned, with headquarters in Glostrup, Denmark. The company has more than 1,400 employees around the globe, with 20 subsidiaries and 50 distributors. Please visit our Web site at www.dako.com.


Source: Dako

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