Lani
10-14-2006, 07:39 AM
perhaps off-label use will ensue:
09.28.06 — Vectibix™ (panitumumab) was approved for metastatic colorectal cancer following priority review by the Food and Drug Administration. Vectibix is expected to be commercially available in October and will be priced lower than Erbitux (cetuximab), another anti-EGFR antibody currently on the market for metastatic colorectal cancer.
The FDA approval of Vectibix was based on a progression-free survival endpoint. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibix is the first entirely human monoclonal antibody for the treatment of patients with metastatic colorectal cancer that expresses the epidermal growth factor receptor (EGFR) after disease progression on or following combination regimens containing fluoropyrimidine, oxaliplatin or irinotecan chemotherapy. Epidermal growth factor receptors are proteins that play an important role in cancer cell signaling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGFR. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.
Vectibix can be conveniently administered intravenously once every two weeks. Side effects included dermatological toxicities—caused by Vectibix blocking the EGF from binding to receptors and inhibition of EGFR-mediated signaling pathways—was reported in 89 percent of patients treated; some cases were severe. Other side effects included fatigue, abdominal pain, nausea and diarrhea.
Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 146,940 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006. Colorectal cancer is the second leading cause of cancer death among men and women in the United States and Canada (after lung cancer). It has been estimated that 56,370 people will die from colorectal cancer in 2006.
Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer. For more information, please visit www.amgentrials.com.
I alluded to this in an earlier post on approval of a HDAC (histone deacetylase inhibitor)
09.28.06 — Vectibix™ (panitumumab) was approved for metastatic colorectal cancer following priority review by the Food and Drug Administration. Vectibix is expected to be commercially available in October and will be priced lower than Erbitux (cetuximab), another anti-EGFR antibody currently on the market for metastatic colorectal cancer.
The FDA approval of Vectibix was based on a progression-free survival endpoint. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix.
Vectibix is the first entirely human monoclonal antibody for the treatment of patients with metastatic colorectal cancer that expresses the epidermal growth factor receptor (EGFR) after disease progression on or following combination regimens containing fluoropyrimidine, oxaliplatin or irinotecan chemotherapy. Epidermal growth factor receptors are proteins that play an important role in cancer cell signaling. Vectibix is an entirely human IgG2 monoclonal antibody that binds with high affinity to EGFR. The goal of developing entirely human monoclonal antibodies is to offer effective targeted therapies with lessened risk of immune response against these agents.
Vectibix can be conveniently administered intravenously once every two weeks. Side effects included dermatological toxicities—caused by Vectibix blocking the EGF from binding to receptors and inhibition of EGFR-mediated signaling pathways—was reported in 89 percent of patients treated; some cases were severe. Other side effects included fatigue, abdominal pain, nausea and diarrhea.
Colorectal cancer is the third most common cancer diagnosed in men and in women in the United States. The American Cancer Society estimated that about 146,940 new cases of colon cancer and 41,930 new cases of rectal cancer will be diagnosed in 2006. Colorectal cancer is the second leading cause of cancer death among men and women in the United States and Canada (after lung cancer). It has been estimated that 56,370 people will die from colorectal cancer in 2006.
Vectibix is being evaluated in ongoing clinical trials as both a monotherapy and in combination with other agents for the treatment of various types of cancer. For more information, please visit www.amgentrials.com.
I alluded to this in an earlier post on approval of a HDAC (histone deacetylase inhibitor)