Pharmaceutical Business review

Amgen gets CHMP negative opinion for Vectibix marketing authorization application

Vectibix is the first fully human anti-EGFR antibody approved by the US Food and Drug Administration (FDA) for the treatment of mCRC.

Amgen will review CHMP’s decision and will decide the next steps to be taken in support of the application, as it believes that Vectibix combined with chemotherapy offers an important treatment option for mCRC patients.