Amgen receives EC approval to extend therapeutic indications for Vectibix

Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has approved a variation to the marketing authorization for Vectibix® (panitumumab) to include indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC) in first-line in combination with FOLFOX and in second-line in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan). This approval of Vectibix applies to all 27 European Union (EU) member states. Prior to this approval, Vectibix had received conditional approval in the EU as monotherapy. The monotherapy indication was also further revised to state that Vectibix is indicated for the treatment of patients with wild-type KRAS mCRC as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

Colorectal cancer is the second most common cancer in women worldwide and the third most common cancer in men. Approximately 1.2 million cases of colorectal cancer are expected to occur globally. With more than 630,000 deaths worldwide per year, it is the third leading cause of cancer-related death in the Western world. The highest incidence rates are found in Japan, North America, parts of Europe, New Zealand, and Australia, and rates are low in Africa and Southeast Asia.

"Colorectal cancer can have a devastating impact on the lives of patients affected by this disease," said Professor Jean-Yves Douillard, director of Clinical and Translational Research, ICO Centre R Gauducheau, France. "This European Commission approval for Vectibix earlier in the treatment continuum marks a welcome and important addition of treatment choice in an area where few targeted agents have shown to be effective when used with chemotherapy."

Data from studies 20050203 (PRIME) and 20050181 ('181) showed that adding Vectibix to either FOLFOX or FOLFIRI chemotherapy improved progression-free survival (PFS) versus chemotherapy alone for patients with wild-type KRAS mCRC. Additionally, the overall response rate (ORR) of Vectibix plus chemotherapy was higher than chemotherapy alone. Although numerically greater, the improvement in median overall survival (OS) did not achieve statistical significance in the Vectibix arm of either trial. The Amgen PRIME and '181 studies were among the first Phase 3 studies to prospectively analyze the effect of an anti-epidermal growth factor receptor (EGFR) inhibitor based on KRAS status in patients with mCRC.

Adverse events in the PRIME and '181 studies included known toxicities associated with EGFR therapy, such as rash, diarrhea, and hypomagnesemia. The incidence of grade 3/4 infusion reactions in the treatment arms for the two trials was approximately one percent.  In patients with mutated KRAS tumors, outcomes were inferior for those receiving Vectibix plus FOLFOX versus FOLFOX alone. Vectibix should only be used in those patients in whom wild-type KRAS status has been confirmed.

"Today's decision by the EC to extend the therapeutic indications for Vectibix marks a promising step forward for those patients facing an aggressive disease where limited treatment options are available," said Willard H. Dere, M.D., senior vice president and international chief medical officer at Amgen. "This is a significant milestone for Amgen and highlights our commitment to deliver medicines that make a real difference to the lives of patients."

Vectibix is already approved and established in more than 40 countries as a monotherapy treatment for patients with wild-type KRAS mCRC, when standard chemotherapy is no longer effective. In the United States (U.S.), Vectibix received accelerated approval in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. The use of Vectibix is not recommended in patients whose tumors have KRAS mutations in codon 12 or 13. In Russia, Japan and Israel, Vectibix is also approved for use in combination with chemotherapy for patients with wild-type KRAS mCRC.

Source:

Amgen Europe GmbH

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