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news.Amgen has submitted a biologic license application to the FDA for panitumumab, an investigational drug for use in the treatment of colorectal cancer that was co-developed with smaller biotech company, Abgenix.
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The potential indication is for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. The rolling biologic license application (BLA) submission was initiated in December 2005.
“The pivotal phase III study of panitumumab not only met the primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer, but the results surpassed our expectations based on preset measurement criteria in the protocol,” said Dr Willard Dere, chief medical officer and senior vice president of Global Development at Amgen.
Amgen and Abgenix previously announced that data from a randomized phase III trial involving 463 patients showed that those who received panitumumab every two weeks showed a 46% decrease in tumor progression rate versus those who received best supportive care alone.
Biotechnology giant Amgen is currently in the process of buying Abgenix for around $2.2 billion.