Breathe Deeply: A Lilly Lung Cancer Drug Offers A Pleasant Surprise

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In a development, Eli reported that a being developed to treat metastatic squamous non-small cell , or NSCLC, increased overall survival in patients during a late-stage trial and there are now plans to seek FDA approval before the end of next year. Although there was precious additional information disclosed, the news was received as a big positive for the drugmaker (see the statement here).

Lilly did note that patients treated with its drug, which is called, necitumumab developed serious, but less frequent adverse events, notably blood clots, indicating a safety issue will be tracked closely. But lung cancer is the leading cause of cancer deaths in the US and NSCLC accounts for 85 percent of all cases. In other words, there is a pressing unmet medical need.

“There is no quantification of the magnitude of the benefit, but given the dearth of therapies to treat this segment of lung cancer patients, achieving overall survival highly likely means the drug will be approved,” Sanford Bernstein analyst Tim Anderson wrote in an investor note. He adds that Lilly has to “validate” manufacturing, suggesting production changes are causing the lag before FDA filing occurs.

“The general tone of the press release doesn’t read as if this was a home run result that will blow people away,” writes ISI Group analyst Mark Schoenabaum in his own investor note. But “the bar (for FDA approval) is relatively low for this disease.” He also points out the drug failed a prior lung trial for safety issues, specifically clotting, and such a caveat could limit market adoption. Still, he forecasts potential annual sales of $ 1.5 billion, if approved.

Why are the results viewed as surprising? Lilly (LLY) and Bristol-Myers Squibb (BMY) were jointly developing the drug, but early last year, Bristol-Myers returned the compound. No explanation was given, but…Read more

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