Amgen, Abgenix complete BLA for FDA approval of panitumumab for colorectal cancer

By Lisa Kerner

Erie, Pa., March 30 - Amgen and Abgenix, Inc. completed the Biologics License Application submission to the Food and Drug Administration for panitumumab in the treatment of metastatic colorectal cancer.

Amgen said the pivotal phase 3 study of panitumumab met the primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer, surpassing the company's expectations.

"Completing the BLA brings us one step closer to realizing our goal of making panitumumab accessible to patients with metastatic colorectal cancer who have failed available treatment options," Amgen's chief medical officer and senior vice president of global development, Willard Dere, said in a company news release.

Previously announced data from a randomized phase 3 trial involving 463 patients showed that those who received panitumumab every two weeks had a 46% decrease in tumor progression rate versus those who received best supportive care alone.

Side effects included acneiform rash, fatigue, nausea and mild diarrhea, the release stated.

Results from the pivotal phase 3 study will be presented in at the 97th Annual Meeting of the American Association for Cancer Research on Monday.

Panitumumab, a monoclonal antibody, targets the epidermal growth factor receptor, a protein that plays an important role in cancer cell signaling, Amgen said.

The antibody received FDA fast track designation in July 2005 and is being evaluated as both a monotherapy and in combination with other agents for the treatment of various cancers, including colorectal, lung and head and neck.

The American Cancer Society estimates that about 106,680 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006.

Located in Thousand Oaks, Calif., Amgen discovers, develops and delivers human therapeutics.

Abgenix is a Fremont, Calif.-based biopharmaceutical company focused on the discovery, development and manufacturing of fully human therapeutic antibodies.

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