CHMP rebuffs Vectibix expansion, backs Cinryze, apixaban

EMA's CHMP issued a number of opinions Friday, including a recommendation against a label expansion of Vectibix panitumumab from Amgen Inc. (NASDAQ:AMGN) to include combination with chemotherapy to treat metastatic colorectal cancer in patients with wild-type K-Ras (KRAS) tumors. CHMP said that although data for Vectibix in combination with chemotherapy showed a "modest increase" in progression-free survival (PFS), the committee questioned its clinical relevance, specifically due to the lack of improvement in overall survival (OS) and quality of life. CHMP also expressed concern about the increased toxicity of the combination of Vectibix with chemotherapy. Furthermore, the committee was concerned about the current reliability of K-Ras testing given the fact that patients with K-Ras mutations receiving Vectibix in combination with chemotherapy experienced a negative effect on PFS and OS. The human mAb against EGFR already has conditional approval in the EU for second-line treatment of colorectal cancer after the failure of chemotherapies in patients with wild-type K-Ras tumors. Amgen was off $0.62 to $52.94 on Friday.

The committee recommended approval of Cinryze from ViroPharma Inc. (NASDAQ:VPHM) to treat and prevent angioedema attacks in patients with hereditary angioedema (HAE). ViroPharma has rights from Sanquin Blood Supply Foundation (Amsterdam, the Netherlands) to market Cinryze worldwide, excluding 11 territories where Sanquin retains rights. Sanquin's Cetor, which is also a C1 esterase inhibitor, is approved in some EU member states to treat acute attacks of angioedema. CHMP noted in its opinion that it considers Viropharma and Sanquin to be the same applicant and Cinryze and Cetor to be the same composition and pharmaceutical form with overlapping indications, factors which it said "may preclude" Cinryze's approval by the EC. ViroPharma said that it was in discussions with EMA but could not speculate on the EC's decision, which it expects next quarter. ViroPharma gained $0.66 to $19.08 on Friday. ...