FDA Approves Amgen's Vectibix For Wild-Type KRAS Metastatic Colorectal Cancer

By Cyndi Root

Amgen announced in a press release that the Food and Drug Administration (FDA) has approved Vectibix (panitumumab). The biologic for use with Folfox, is indicated for patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC). The FDA also approved a companion diagnostic test, the therascreen KRAS RGQ PCR Kit. The approval advances personalized medicine, as the new therapy uses genetic markers to target cancer treatment.

Sean E. Harper, M.D., EVP of Research and Development at Amgen said, "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.”

Vectibix and Folfox

Vectibix (panitumumab) is a fully human anti-EGFR antibody. It was first approved in 2006 for monotherapy treatment of EGFR-expressing mCRC, after prior treatment with chemotherapy. The new approval is for combination therapy with Folfox, an oxaliplatin-based chemotherapy regimen. The FDA based its approval in part on the PRIME trials, which showed statistically significant improvement in progression-free survival (PFS) with Vectibix and Folfox, compared to Folfox alone. The results also showed a 4.4 month improvement in overall survival (OS) versus Folfox alone. The ASPECCT trials showed that Vectibix was non-inferior in overall survival to Erbitux (cetuximab).

KRAS RGQ PCR Kit

The KRAS RGQ PCR Kit (therascreen KRAS test) was developed by QIAGEN, and was approved by the FDA as a companion diagnostic to the Vectibix and Folfox regime. In its press release, QIAGEN said that this represents only the third time that the FDA has approved a diagnostic with a novel medicine. The test guides treatment by identifying patient subgroups most likely to benefit from Vectibix and Folfox treatment, and helps determine the best way to administer treatment.

QIAGEN is a Netherlands-based company that isolates and processes DNA, RNA, and proteins from biological samples. QIAGEN has five master collaboration agreements with pharmaceutical companies and more than 15 project agreements with other companies. QIAGEN’s tests are FDA approved with Erbitux and Gilotrif. In Europe, tests are approved for patients with brain tumors (gliomas) and in China for non-small cell lung cancer (NSCLC). QIAGEN launched companion tests in Japan in 2011.