EMA extends approval of Vectibix plus FOLFIRI as first-line treatment for wild-type RAS mCRC

Amgen (NASDAQ: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion to extend the marketing authorization for Vectibix^® (panitumumab) to include combination with FOLFIRI (an irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC). About half of the patients with mCRC have wild-type RAS tumors.

"Adding Vectibix to chemotherapy as first-line treatment in patients with wild-type RAS metastatic colorectal cancer has been shown to result in better responses than chemotherapy alone," said Elliott M. Levy, M.D., senior vice president of Global Development at Amgen. "The CHMP recommendation is an important step toward increasing the treatment options for patients with this aggressive disease and helping improve outcomes in the European Union."

The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. Vectibix is already approved in the European Union (EU) for the treatment of adult patients with wild-type RAS mCRC:

• in first-line in combination with FOLFOX.
• in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).
• as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The CHMP positive opinion will now be ratified by the European Commission who, should they affirm the CHMP opinion, will extend the centralized marketing authorization which is valid in the 28 countries that are members of the EU, as well as European Economic Area members, Iceland, Lichtenstein and Norway.

The safety profile of Vectibix was consistent with previously reported studies.

Colorectal cancer is the third most common cancer worldwide, with approximately 1.2 million cases expected to occur globally. The highest estimated mortality rates associated with colorectal cancer occur in Central and Eastern Europe.

Source: http://www.amgen.com/