Vectibix is the first fully human monoclonal anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.
In May 2014, the FDA approved Vectibix for use in combination with FOLFOX, as first-line treatment in patients with wild-type KRAS (exon 2) mCRC. With this approval, Vectibix became the first-and-only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens, in the first-line treatment of mCRC for patients with wild-type KRAS mCRC.
In June 2017, the FDA approved a refined indication for Vectibix for use in in patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) mCRC.
Colorectal cancer (CRC) originates in the colon or rectum and often begins as a benign polyp that can develop into an invasive tumor. A key factor in CRC treatment involves testing for genetic markers like the epidermal growth factor receptor (EGFR) and mutations in the RAS gene family (KRAS and NRAS). For patients with metastatic CRC (mCRC) who express EGFR and have wild-type RAS genes, targeted therapies like VECTIBIX (panitumumab) are effective. VECTIBIX targets EGFR, inhibiting signals that promote tumor growth, and is used alone or with chemotherapy, enhancing outcomes such as progression-free and overall survival.
Companion diagnostic testing plays a crucial role in the treatment of colorectal cancer with VECTIBIX. It involves testing the cancer for the presence of specific biomarkers—particularly, the KRAS gene. VECTIBIX is indicated only for patients whose tumors are KRAS wild-type, meaning they lack mutations in the KRAS gene. This testing ensures that VECTIBIX is used for patients most likely to benefit from this targeted therapy, as the presence of KRAS mutations is associated with resistance to EGFR inhibitors like VECTIBIX.
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This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
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