Amgen's Vectibix (panitumumab) receives EC approval for treatment patients with WT RAS mCRC

Amgen (NASDAQ: AMGN) today announced that the European Commission approved a new use of Vectibix® (panitumumab) as first-line treatment in combination with FOLFIRI for the treatment of adult patients with wild-type (WT) RAS metastatic colorectal cancer (mCRC). About half of the patients with mCRC have WT RAS tumors. FOLFIRI, an irinotecan-based chemotherapy regimen, is frequently used in first-line colorectal cancer treatment in Europe.

"Colorectal cancer is the second most common cancer in Europe, and additional treatment options are important for patients and for physicians treating this serious disease," said Elliott M. Levy, M.D., senior vice president of Global Development at Amgen. "The European Commission approval of Vectibix as a first-line treatment in combination with FOLFIRI chemotherapy means physicians have another treatment option for adult patients with wild-type RAS metastatic colorectal cancer."

The new indication is based upon studies that evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is now approved in the European Union (EU) for the treatment of adult patients with WT RAS mCRC: in first-line in combination with FOLFOX or FOLFIRI; in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan); and as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Colorectal cancer is the third most common cancer worldwide, with approximately 1.2 million cases expected to occur globally. Colorectal cancer is the second most common cancer in Europe, with approximately 470,000 new cases each year; the highest incidence rate of colorectal cancer in the world. It is also the second greatest cause of cancer death in Europe following lung cancer, accounting for 12 percent of all cancer deaths.

Source:

Amgen

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