FDA Approves Option for Wild-Type RAS Metastatic Colorectal Cancer
The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for Vectibix (panitumumab) for the treatment of patients with wild-type KRAS or wild-type NRAS metastatic colorectal cancer (mCRC). This is the first fully human monoclonal anti-epidermal growth factor receptor antibody approved by the FDA for this patient population.
Vectibix was indicated as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.
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Data from clinical trials were used to determine the efficacy of Vectibix for patients with wild-type KRAS MCRC and patients with wild-type RAS MCRC. Patients who received Vectibix in combination with best supportive care had a statistically significant improvement in overall survival of 10 months compared to the overall survival of 6.9 months for patients who only received best supportive care.
Common adverse reactions reported in 20% or more of patients taking Vectibix as a monotherapy included skin rash, paronychia, fatigue, nausea, and diarrhea. Additionally, common adverse reactions for patients who received Vectibix in combination with FOLFOX included diarrhea, stomatitis, mucosal inflammation, asthenia, paronychia, anorexia, hypomagnesemia, hypokalemia, rash, acneiform dermatitis, pruritus, and dry skin. Serious adverse reactions included dehydration and diarrhea.
In addition, the FDA approved the first multigene, next generation sequencing-based test to identify the RAS mutation status of patients with colorectal cancer, which would help physicians identify patients who would most likely benefit from Vectibix therapy.
FDA approves Vectibix® (panitumumab) For use in wild-type RAS metastatic colorectal cancer [press release]. Thousand Oaks, CA: Amgen News Releases; June 29, 2017. http://wwwext.amgen.com/media/news-releases/2017/06/fda-approves-vectibix-panitumumab-for-use-in-wildtype-ras-metastatic-colorectal-cancer/. Accessed June 30, 2017.