FDA panel: Lilly cancer drug has positive risk/benefit profile
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(Reuters) - An advisory panel to the U.S. Food and Drug Administration effectively supported approval of Eli Lilly & Co.'s (NYSE: LLY) experimental lung cancer drug necitumumab on Thursday but recommended measures be taken to mitigate the drug's risks.
The panel did not officially vote but an informal poll taken by the FDA indicated most members believe the benefits of the drug outweigh the risks. The FDA is not obliged to follow the advice of its advisors but generally does so.
In a clinical trial, the drug improved overall survival by an average of 1.6 months but also increased the risk of sometimes fatal blood clots and potentially deadly electrolyte imbalances.
Necitumumab is a second-generation monoclonal antibody for patients with stage IV squamous non-small cell lung cancer.
(Reporting by Toni Clarke in Washington; Editing by Bill Trott)
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