Amgen to appeal CHMP opinion on Vectibix

Amgen has announced that it is to appeal the negative opinion issued by the European Committee for Medicinal Products for Human Use (CHMP) regarding the company’s application for marketing approval for Vectibix (panitumumab).

The company submitted an application for authorisation of the compound as a treatment for metastatic colorectal cancer (mCRC) patients who have already failed treatment with chemotherapy.

Following the adoption of a negative recommendation by the committee, Amgen reports that it will request a re-examination of this opinion through the proper appeals procedure.

Vectibix is a fully-human IgG2 monoclonal antibody that targets epidermal growth factor receptor with the aim of affecting cancer-cell signalling, with the compound already approved by the US Food and Drug Administration last September for its efficacy in lengthening progression-free survival.

“Amgen is confident that the available data demonstrates that Vectibix improves progression-free survival for mCRC patients who have progressed on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens,” the company reports.

Earlier this month, Amgen announced the publication of results of a phase III clinical trial of the compound in the Journal of Clinical Oncology.

These results showed that administration with Vectibix increased progression-free survival in mCRC patients who have failed certain chemotherapy regimens compared to best supportive care.