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.
Isofol’s chemotherapy-enhancing drug doesn’t move the needle in advanced colorectal cancer
Sweden-based Isofol’s lead candidate, a chemotherapy-enhancing drug, flunked a Phase III study in metastatic colorectal cancer, or mCRC, the biotech said Wednesday.
In almost 500 patients in the AGENT study, compared to leucovorin — which is currently used to complement chemotherapy — Isofol’s arfolitixorin did not significantly change the overall response rate, which was the primary endpoint, or progression-free survival, the key secondary outcome.
In a press release, Isofol CEO Ulf Jungnelius said the biotech was “surprised and disappointed” by the trial outcome. He added that Isofol will first complete the data analysis and plans to consult regulatory agencies in the first half of next year prior to deciding the fate of its lead candidate.
The Phase III flunk cratered Isofol’s stock, as it dropped some 80% yesterday.
Isofol said the full results from the study, including subgroup analyses and safety data, will be available later this year. The FDA granted arfolitixorin fast-track designation in late 2021.