Amgen's drug Vectibix (Panitumumab), in combination with chemotherapy regimen FOLFOX, can now be used as first line of treatment for patients with the wild-type KRAS or metastatic colorectal cancer (mCRC) type, following an extended approval by the U.S. Food and Drug Administration (FDA).
The FDA approval, announced by Amgen on May 23, makes Vectibix the first and sole biologic to provide a substantial survival benefit as first line of treatment with chemotherapy FOLFOX. The recent approval also changes the previous accelerated monotherapy approval of Vectibix to what is now a full approval for said drug.
FDA similarly approved QIAGEN's therascreen KRAS test, which would serve as Vectibix's companion diagnostic.
Vectibix's extended approval and announcement marks the newest milestone in the groundbreaking cancer biomarker research of Amgen, which aims to help oncologists provide personalized cancer treatment so as to advance the results in patients.
"Because every patient with cancer is unique, we have made it our mission to focus on identifying treatment options for patients based on their cancer's genetic makeup," Dr. Sean E. Harper, executive vice president at Amgen's Research and Development, says in a statement.
Dr. Harper adds that the extended approval of Vectibix for use in combination with chemotherapy FOLFOX exemplifies the developments which can be done through better understanding of individual genetic markers that are related with diseases considered to be difficult to cure.
Amgen further says that the FDA approval was based on gathered results from trials made by the drug company, showing that patients having wild-type KRAS tumors significantly improved with a 4.4 month overall survival progress, when under the combination treatment of Vectibix and FOLFOX chemo rather than solely depending on the latter chemo treatment.
Research says Vectibix got its first approval in 2006 for treatment in patients with colon cancer, which has already spread. Usual side effects of using said drug are nausea, fatigue, skin rash, constipation and diarrhea.
Amgen recorded a $389 million worth of Vectibix sales in 2013, of which $126 million came from sales in the U.S.
The American Cancer Society says colorectal cancer is said to be third of the most-common types of cancer that is found in both women and men in the U.S. and is also considered as the second primary cause of deaths from cancer. It is expected that about 1.2 million colorectal cancer cases will occur worldwide. In the U.S. alone, an estimate of 137,000 new cases is expected this year, with over 50,000 deaths from it as well.