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) (Amgen) 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 (HRAS, KRAS and NRAS) 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.
Within the European Union Vectibix is presently indicated for the treatment of patients with wild-type KRAS (exon 2 in codons 12 or 13) metastatic colorectal cancer (mCRC), determined by an FDA-approved test, as the primary option when combined with FOLFOX or as a monotherapy following disease progression after previous therapy with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
Before potential treatment with Vectibix, KRAS mutational status in colorectal tumors should be determined for patient selection. Vectibix is not indicated as a therapy for patients with KRAS-mutant mCRC or if the KRAS mutation status is not known. Also, vectibix combined with oxaliplatin-based chemotherapy is not an adequate therapy for patients with RAS-mutant mCRC or if RAS mutation status is not known.
The European Commission will approve CHMP’s positive opinion concerning the extended commercialization of Vectibix in 28 EU member countries, as well as those in the European Economic Area such as, Iceland, Lichtenstein and Norway.
