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Stock impact report

FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo [Yahoo! Finance]

Arvinas, Inc. (ARVN) 
Last arvinas, inc. earnings: 11/4 05:00 pm Check Earnings Report
Company Research Source: Yahoo! Finance
It can be inferred that the ODAC thinks the risk of treatment with the Blenrep combo currently appears to outweigh its benefit profile at the proposed dose for treating adults with relapsed or refractory multiple myeloma. Shares of GSK were down 4.7% yesterday following the announcement of the news. The ODAC's opinion comes just a week ahead of the FDA's final decision on its review of GSK's biologics license application (BLA), which sought approval of Blenrep in combination with J&J's Velcade (bortezomib) plus dexamethasone (BorDex) or Bristol Myers' Pomalyst (pomalidomide) plus dexamethasone (PomDex) for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. Given that the FDA usually considers the ODAC opinion, it can be inferred that the regulatory body might reject the approval for the Blenrep combo in the United States. Year to date, shares of GSK have risen 7.8% against the industry's decrease of 0.6%. Image Source: Zack Show less Read more
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