publication date: May. 30, 2014


Approvals.html

Drug Approvals

FDA Approves Vectibix in mCRC with KRAS Companion Diagnostic


FDA approved the Amgen agent Vectibix (panitumumab) for use in combination with FOLFOX as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer.

With this approval, Vectibix becomes the first and only biologic to offer a significant survival benefit as a first-line treatment with FOLFOX. In addition, this approval converts the accelerated monotherapy approval to a full approval for Vectibix.

FDA also approved the therascreen KRAS RGQ PCR Kit developed by Qiagen as a companion diagnostic for Vectibix.

The approval is based on results from Amgen’s PRIME and ASPECCT trials. The PRIME phase III trial showed that patients with wild-type KRAS tumors in exon 2 achieved statistically significant improvement in progression-free survival with Vectibix and FOLFOX, compared to FOLFOX alone (9.6 vs. 8.0 months, p=0.02) and a significant 4.4 month improvement in overall survival versus FOLFOX alone (23.8 vs. 19.4 months).

The phase III 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 the first fully human anti-EGFR antibody approved by the FDA for the treatment of mCRC. Vectibix was 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.


THE EUROPEAN MEDICINES AGENCY’S Committee for Medicinal Products for Human Use issued … Continue reading 40-22 Drug Approvals: FDA Approves Vectibix in mCRC Along with KRAS Diagnostic

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