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Amgen seeks re-evaluation of CHMP negative opinion on Vectibix

Amgen has appealed the European Medicines Agency (EMA) for the re-evaluation of the negative opinion issued by the Committee For Medicinal Products for Human Use (CHMP) for the use of Vectibix in combination with chemotherapy for patients who are suffering from wild-type KRAS metastatic colorectal cancer (mCRC).

Amgen claims that Vectibix, in conjuction with chemotherapy, offers an an important treatment option for patients with wild-type KRAS mCRC.

Accoding to the company, the results from the studies 20050203 (PRIME) and 20050181 (181) demonstrated that adding Vectibix to Folfox and Folfiri chemotherapy, showed improved progression-free survival (PFS) versus chemotherapy alone in patients with wild-type KRAS mCRC.

The trials proved that the patients taking this combination have a greater chance of living longer without their disease getting worse.