New Indication for Vectibix
June 29, 2017 – The U.S. FDA has approved a new indication for Vectibix® (panitumumab), manufactured by Amgen, to treat patients with metastatic wild-type RAS colorectal cancer. Vectibix can be used as initial therapy in combination with FOLFOX (folinic acid, fluorouracil and oxaliplatin), or by itself for patients with cancer that has progressed despite prior chemotherapy with fluoropyrimidine, oxaliplatin, and irinotecan. Along with the new indication, the FDA has approved a companion diagnostic test to validate RAS status. Recommended dosing is once every two weeks at 6mg/kg infused intravenously (IV) over 30 minutes to 90 minutes, depending on the size of the dose.
Vectibix carries a black box warning that 90% of patients using it as monotherapy in clinical trials developed skin reactions that ranged from dry, itchy skin to cracks and shedding. Approximately 15% of patients experienced severe reactions. Vectibix carries several other colorectal cancer indications, and has been available on the U.S. market since late 2006.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.