FDA approves panitumumab plus FOLFOX for wild-type KRAS metastatic colorectal cancer

FDA has approved panitumumab (Vectibix, Amgen) 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).

Vectibix is the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX, a commonly used chemotherapy regimens in the first-line setting for patients with wild-type KRAS mCRC.

FDA also approved the therascreenKRAS RGQ PCR Kit from QIAGEN (therascreenKRAS test) as a companion diagnostic for Vectibix.

“This approval is also an example of the advancements that can be made through a greater understanding of distinct genetic markers associated with difficult to treat diseases. Through the use of biomarkers, such as KRAS, we have been able to help ensure that the right patients receive the right treatment. This approval also offers patients and oncologists an additional option to treat patients with Vectibix plus FOLFOX, and may offer patients additional benefits,” according to a company statement.

The approval is based on results from Amgen's PRIME ('203) and ASPECCT ('763) 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 vs 8.0 months, P=.02) and a significant 4.4 month improvement in overall survival (OS) versus FOLFOX alone (23.8 vs 19.4 months).

The phase 3 ASPECCT study met its primary end point of non-inferiority for improving overall survival in patients taking Vectibix versus cetuximab as a single agent for the treatment of mCRC in patients with wild-type KRAS tumors who have not responded to chemotherapy.  

Vectibix was previously approved in the United States 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.