Amgen announced that the U.S. Food and Drug Administration (FDA) has approved Vectibix (panitumumab) for use in combination with Folfox, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). With this approval, Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with Folfox, one of the most commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC. In addition, this approval converts the accelerated monotherapy approval to a full approval for Vectibix. The FDA also approved the therascreen KRAS RGQ PCR Kit developed by QIAGEN (therascreenKRAS test) as a companion diagnostic for Vectibix.
The announcement is the latest milestone in Amgen’s pioneering cancer biomarker research, aimed at helping oncologists personalize cancer treatment to improve patient outcomes. Biomarkers are biological characteristics that demonstrate the likelihood of an individual’s response or lack of response to a particular therapy and are a key element in personalized medicine that can help oncologists choose treatments for patients who are most likely to benefit.
“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,” said Sean Harper, executive vice president of Research and Development at Amgen. “Approval of Vectibix in combination with FOLFOX for first-line treatment of patients with wild-type KRAS metastatic colorectal cancer is an example of the advancements that can be made through a greater understanding of distinct genetic markers associated with difficult-to-treat diseases.”
The approval is based on results from Amgen’s PRIME and ASPECCT trials. The PRIME Phase 3 study showed that patients with wild-type KRAS tumors in exon 2 achieved statistically significant improvement in progression-free survival (PFS) with Vectibix and Folfox versus Folfox alone (9.6 versus 8.0 months, p=0.02) and a significant 4.4 month improvement in overall survival (OS) versus Folfox alone (23.8 versus 19.4 months).
The Phase 3 ASPECCT study met its primary endpoint of non-inferiority for improving overall survival in patients taking Vectibix versus Erbitux (cetuximab) as a single agent for the treatment of mCRC in patients with wild-type KRAS tumors who have not responded to chemotherapy.
“Vectibix is now the first approved biologic to show a significant survival benefit when combined with Folfox as a first-line treatment,” said Lee Schwartzberg, medical director of The West Clinic, Memphis, Tenn. “Vectibix has shown a significant benefit to patients with wild-type KRAS metastatic colorectal cancer when used with Folfox, which gives us a valuable new treatment option as we help patients fight this devastating disease.”
Colorectal cancer is the third most common cancer found in both men and women in the United States, and is the second leading cause of cancer deaths. Approximately 1.2 million cases of colorectal cancer are expected to occur globally.
Date: May 23, 2014
Filed Under: Drug Discovery