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Saturday, Sep 23, 2023

Amgen to Support FDA Approval for Biocartis Cancer Test

Amgen Inc. in Thousand Oaks has agreed to provide operational and financial support to Belgium-based Biocartis Group in its pursuit of Food and Drug Administration approval for a test that compliments Amgen’s metastatic colon cancer drug Vectibix, or panitumumab. “Amgen has been a pioneer in personalized medicine for colorectal cancer, and we are committed to advancing patient care with the identification of appropriate biomarkers to aid optimal treatment selection,” Greg Friberg, vice president of global development in oncology at Amgen, said in a statement. The test, called Idylla, determines whether patients with metastatic colorectal cancer would benefit from Vectibix by detecting the presence of a gene mutation in tumor tissue. Testing for the mutation is currently not routine in the U.S. Amgen and Biocartis have previously collaborated to offer the test to patients in Europe as well as in Canada and countries in South America and the Middle East. Under the latest agreement – the financial terms of which were not disclosed – Biocartis will use backing from Amgen to pursue premarket approval for Idylla from the FDA. Making the test available in the U.S. would expand the market for Vectibix by enabling oncologists to know whether the drug should be included in a patient’s treatment plan. Amgen stock (AMGN) rose $1.49, or less than 1 percent, on Monday to close at $178.69 on the Nasdaq.

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