Lilly's latest lung cancer contender lines up for FDA scrutiny

Eli Lilly ($LLY), angling for FDA approval for its newest lung cancer treatment, has a July 9 date with a panel of independent agency advisers, a crucial hurdle in the regulatory process. The antibody, necitumumab, is designed to fight nonsquamous non-small cell lung cancer by blocking EGFR, key to tumor growth. In Phase III trials, a combination of necitumumab and chemotherapy extended overall survival by by about 1.6 months compared to chemo alone, middlingly positive results that underwhelmed analysts. The FDA's Oncologic Drugs Advisory Committee will vote on whether to recommend Lilly's antibody for full approval, handing up a recommendation that is most often followed by the agency at large. More

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