Amgen's Colon Cancer Drug Vectibix Gets Expanded FDA Approval

(RTTNews) - Biotech giant Amgen Inc. (AMGN) said Friday that the U.S. Food and Drug Administration has approved Vectibix for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS metastatic colorectal cancer.

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 with Vectibix and FOLFOX versus FOLFOX alone and a significant 4.4 month improvement in overall survival versus FOLFOX alone.

The Phase 3 ASPECCT study met its primary endpoint of non-inferiority for improving overall survival in patients taking Vectibix versus Erbitux® as a single agent for the treatment of metastatic colorectal cancer in patients with wild-type KRAS tumors who have not responded to chemotherapy.

Vectibix now 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 metastatic colorectal cancer. In addition, the approval converts the accelerated monotherapy approval to a full approval for Vectibix.

The FDA has also approved the therascreen®KRAS RGQ PCR Kit developed by Qiagen NV (GQEN) as a companion diagnostic for Vectibix.

Vectibix was earlier approved in the U.S. in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy.