With Libtayo now squarely in Regeneron’s hands, the drugmaker is eager to start cranking out combination therapies. But one near-term prospect is expected to suffer a delay.
Regeneron’s Libtayo-chemotherapy combo in advanced squamous or nonsquamous non-small cell lung cancer is unlikely to clinch approval until after its FDA action date next month, Regeneron’s CEO said on a call with investors Wednesday.
While the company is “pleased” with the progress the FDA’s made so far on its review of the Libtayo lung cancer combo, “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 helmsman Len Schleifer, M.D., Ph.D., said on the call.
The delay should be brief, Schleifer stressed. A new site inspection has been scheduled, and Regeneron does “not expect a lengthy extension of review period,” Schleifer said. The delay would not “meaningfully impact our launch plans, assuming FDA approval,” he added.
Back in June, Regeneron laid out $900 million to pick up exclusive worldwide rights to Libtayo from its partner Sanofi. With rights to the drug, the company “will have the freedom to explore combination opportunities in our pipeline with existing collaborators and with future partners, while realizing a greater share of the potential upside from these investments,” Schleifer said earlier this summer.
Meanwhile, the FDA inspection update came as Regeneron’s second quarter revenues slipped a whopping 44% to $2.86 billion.
Even still, that precipitous decline doesn’t tell the whole story. Taking sales of the company’s COVID-19 antibody cocktail REGEN-COV out of the mix, revenues increased 20% versus the same period in 2021, Regeneron said in a release.