FDA Green Light for Amgen (AMGN) Colorectal Cancer Drug Vectibix
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Excluding skin cancers, colorectal cancer is the third most common cancer diagnosed in both men and women in the United States. The American Cancer Society's estimates for the number of colorectal cancer cases in the United States for 2014 are:
* 96,830 new cases of colon cancer
* 40,000 new cases of rectal cancer
Colorectal cancer is the third leading cause of cancer-related deaths in the United States when men and women are considered separately, and the second leading cause when both sexes are combined. It is expected to cause about 50,310 deaths during 2014.
Amgen Inc. (AMGN) reported that the U.S. Food and Drug Administration (FDA) has approved its Vectibix(R) (panitumumab) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen (one of the most commonly used), as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC).
With this approval, AMGN's Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX, one of the most commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC.
In addition, this approval converts the accelerated monotherapy approval to a full approval for AMGN's Vectibix, a fully human anti-EGFR antibody.
AMGN is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
More about Amgen Inc. (AMGN) at www.amgen.com
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Qiagen NV (QGEN) reported that its therascreen(R) KRAS RGQ PCR Kit (therascreen KRAS test) has received FDA approval to guide the treatment of metastatic colorectal cancer patients with Amgen's Vectibix.
This marks the third FDA approval of a companion diagnostic from QGEN that has been paired with a novel medicine.
KRAS mutations, occurring in approximately 40% of colorectal cancer patients, influence response to anti-EGFR therapies such as Vectibix and Erbitux. Screening colorectal cancer patients with QGEN's therascreen KRAS detects the most frequent mutations in the KRAS gene and helps to guide treatment planning.
QGEN is the leading global provider of Sample & Assay Technologies that are used to transform biological materials into valuable molecular information. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are then used to make these isolated biomolecules visible and ready for interpretation.
More about Qiagen NV (QGEN) at www.qiagen.com.
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CRWE-PR Finance www.finance.crwe-pr.com/2014/05/25/fda-green-light-for-amgen-amgn-colorectal-cancer-drug-vectibix-and-for-qiagen-qgen-kras-rgq-pcr-kit-to-accompany-it
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