July 10, 2017

FDA Approves Vectibix® Precision Colon Cancer Medicine For Use In Advanced Colorectal Cancer

By cancerconnect

The U.S. Food and Drug Administration (FDA) has approved Vectibix® (panitumumab), a precision cancer medicine for the initial treatment of patients with wild-type RAS metastatic colorectal cancer.  Vectibix may be used as first-line therapy in combination with FOLFOX or as single agent therapy following disease progression after prior treatment with oxaliplatin, and irinotecan-containing chemotherapy.1

About Colorectal Cancer

Colorectal cancer remains the second-leading cause of cancer-related death in the United States.  Colorectal cancer is the third most common cancer found in both men and women with approximately 135,000 individuals diagnosed in 2016.1 Approximately 20 percent of colon cancers are diagnosed at the metastatic stage when the disease has already spread to distant organs, a diagnosis associated with only a 12 percent five-year survival rate.1

About Vectibix®

Vectibix is a precision cancer medicine that inhibits cancer cell growth and survival by targeting a protein known as the epidermal growth factor receptor (EGFR).  Precision Cancer Medicine.is now considered one of the pillars of cancer therapy, joining the three longstanding pillars or surgery, radiation therapy and chemotherapy.  Precision cancer medicine uses targeted drugs and immunotherapies engineered to directly attack the cancer cells with specific abnormalities, leaving normal cells largely unharmed.

Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of metastatic colon cancer with wild type RAS.  An estimated 40–50% of metastatic colorectal cancers contain a gene known as KRAS. Vectibix specifically benefits patients whose cancers are EGFR positive and do not contain the KRAS mutation. This is refereed to as wild-type RAS.

Using molecular approaches to identify unique genetic signatures in mCRC has the potential to help improve treatment outcomes.  The FDA has also recently approved the first multi-gene test to identify the RAS mutation status of a patient's cancer. This companion diagnostic test helps physicians identify patients that are most likely to benefit from treatment with Vectibix.

The approval of Vectibix for the treatment of patients with wild-type RAS colon cancer was based on an analysis from a clinical study comparing Vectibix plus best supportive care (BSC) to BSC alone in patients with advanced chemo-refractory, wild-type KRAS colon cancer. Vectibix improved overall survival compared to BSC alone.

The full approval for Vectibix as a treatment for patients with wild-type RAS colon cancer provides physicians and the patients with another targeted treatment for a more personalized approach to the treatment of individuals with colon cancer.

Individuals with advanced colorectal cancer should discuss testing for KRAS and other markers to ensure they are eligible to take advantage of newer precision cancer medicines increasingly available for the treatment of colorectal cancer.


  1. http://investors.amgen.com/phoenix.zhtml?c=61656&p=irol-newsArticle&ID=1934128
  2. American Cancer Society. Key Statistics for Colorectal Cancer. http://www.cancer.org/cancer/colonandrectumcancer/detailedguide/colorectal-cancer-key-statistics.

Tags: colorectal cancer, EFGR, News Tips and Features, News Tips and Features Other, panitumumab, Precision Cancer Medicine, vectibix