FDA delays PDUFA date for Libtayo lung cancer combo; Swedish biotech hit flunks PhIII for chemo-enhancing drug

During its earnings call yesterday, Regeneron said that the FDA has delayed its decision on Libtayo in combination with chemotherapy in advanced non-small cell lung cancer.

“We recently were informed that an FDA travel complication relating to scheduling a routine clinical trial site inspection in Eastern Europe will likely delay their decision until after our September 19 PDUFA date,” Regeneron president and CEO Len Schleifer said during the call.

He added that a new inspection date has already been scheduled, so the delay shouldn’t be too lengthy and that Regeneron doesn’t “expect it to meaningfully impact our launch plans assuming FDA approval.”

In early June, Regeneron inked a $1 billion-plus deal with its partner Sanofi to buy the exclusive rights to Libtayo, plopping down a lofty $900 million upfront.

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