Vectibix™ is indicated as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The effectiveness of Vectibix™ as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival (see CLINICAL STUDIES). Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix™.

Important Product Safety Information

As described below, the Vectibix™ Prescribing Information includes warning language as part of evolving FDA labeling for the anti-EGFr class:

Dermatologic Toxicity:  Dermatologic toxicities, related to Vectibix™ blockade of EGF binding and subsequent inhibition of EGFR-mediated signaling pathways, were reported in 89% of patients and were severe (NCI-CTC grade 3 and higher) in 12% of patients receiving Vectibix™ monotherapy. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Severe dermatologic toxicities were complicated by infection including sepsis, septic death, and abscesses requiring incisions and drainage. Withhold or discontinue Vectibix™ and monitor for inflammatory or infectious sequelae in patients with severe dermatologic toxicities.

Infusion Reactions: Severe infusion reactions occurred with the administration of Vectibix™ in approximately 1% of patients. Severe infusion reactions were identified by reports of anaphylactic reaction, bronchospasm, fever, chills, and hypotension. Although fatal infusion reactions have not been reported with Vectibix™, fatalities have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix™. 

Other important safety information includes:

The most common adverse events observed in clinical studies of Vectibix™ (n = 1467) were skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea. The most serious adverse events observed were pulmonary fibrosis, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation. Adverse events requiring discontinuation of Vectibix™ were infusion reactions, severe skin toxicity, paronychia, and pulmonary fibrosis.