The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA) gave a positive opinion to extend the
marketing authorization for Vectibix (panitumumab)
to be included in combination with FOLFIRI (an irinotecan-based
chemotherapy) as first option treatment for adult patients with
wild-type RAS metastatic colorectal cancer (mCRC).
Colorectal cancer is the third most frequent cancer in the world,
with an average 1.2 million cases are expected to occur worldwide.
Central and Eastern Europe are the regions with the higher expected
death rates associated with colorectal cancer. The RAS proto-oncogenes codify a family of GDP/GTP-regulated switches that send extracellular
signals to regulate the growth and survival properties of cells. In
human tumors RAS family members are normally found in their mutated, oncogenic forms.
Vectibix (panitumumab) is a
recombinant, human IgG2 kappa monoclonal antibody that specifically
targets the human epidermal growth factor receptor (EGFR). Alterations
in EGFR have been associated with development of several of tumors.
Therefore, specific EGFR inhibition is one of the important targets for
cancer treatment.
Dr. Elliott M. Levy, senior vice president of Global Development at
Amgen, said in a news release that the combination of Vectibix
with chemotherapy as a first treatment option for patients with
wild-type RAS metastatic colorectal cancer has provided better
responses than chemotherapy alone. “The CHMP recommendation is an
important step toward increasing the treatment options for patients with
this aggressive disease and helping improve outcomes in the European
Union,” added Dr. Levy.
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