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FDA approves Vectibix plus FOLFOX to treat wild-type KRAS mCRC

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The FDA recently approved panitumumab for use combined with FOLFOX as first-line treatment in patients with wild-type KRAS metastatic colorectal cancer, according to an Amgen press release.

This approval converts the previous accelerated monotherapy approval for the treatment of patients with EGFR-expressing metastatic colorectal cancer (mCRC) following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy to a full approval for panitumumab (Vectibix, Amgen).

“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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in a press release. “Approval of Vectibix in combination with FOLFOX for first-line treatment of patients with wild-type KRAS [mCRC] is an example of the advancements that can be made through a greater understanding of distinct genetic markers associated with difficult-to-treat diseases.”

 

Lee S. Schwartzberg

The FDA approval was 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 PFS with panitumumab and FOLFOX vs. FOLFOX alone (9.6 vs. 8 months; P=.02) and a significant 4.4-month improvement in OS vs. FOLFOX alone (23.8 vs. 19.4 months).

The phase 3 ASPECCT study met its primary endpoint of noninferiority for improving OS in patients taking panitumumab vs. cetuximab (Erbitux, Eli Lilly) 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 S. Schwartzberg, MD, medical director of The West Clinic in Memphis, Tenn. “Vectibix has shown a significant benefit to patients with wild-type KRAS [mCRC] when used with FOLFOX, which gives us a valuable new treatment option as we help patients fight this devastating disease.”