FDA, New Products

A speedy FDA offers lightning review and quick OK for the latest PD-1 from Regeneron and Sanofi

The FDA really didn’t need until the end of October to decide on whether it wanted to approve cemiplimab, the world’s 6th PD-1/L1 from Sanofi and Regeneron. Regulators flagged it through on Friday evening, happy to see the field crowd up as a top collaboration team cruised to a win ahead of a priority review deadline.

The drug will be sold as Libtayo for advanced cutaneous squamous cell carcinoma. Investigators came up with a 46.3% ORR for advanced CSCC in their key study and plan to sell the therapy with a wholesale acquisition cost of $9,100 per three-week treatment cycle. Patients will be eligible for copay support.

“These patients often have advanced disease with limited treatment options, and are often elderly with comorbidities,” said oncologist Danny Rischin about the data. “Some patients on the trial were only estimated to live for a few months, and are back to living normal lives at nearly 2 years now. It’s quite remarkable compared with the options previously.”

Regeneron and Sanofi both willingly anted up $1 billion recently to help accelerate their work here, looking to make a splash in a field that has been clearly dominated by mega blockbusters from Merck and Bristol-Myers Squibb.

Both companies still have high hopes for the overall market opportunity, as a lineup of majors that also includes the likes of Roche, AstraZeneca and Pfizer/Merck KGaA grapple with the two top players for a slice of a blockbuster market. Regeneron investigators in particular highlighted their belief that while there may be significant similarities in some of these rival drugs, they believe that cemiplimab in particular will stand out as a top-ranked PD-1, with clear advantages over the 3 PD-L1 drugs in the market.

One thing is for certain, though. This won’t be the last of the PD-1/L1 crowd.

The Cancer Research Institute ran a study that found 164 PD-1/L1s in the pipeline, from preclinical through marketing stages. Novartis has one in development solely for in-house use. And we may find a few thrown in as low-priced commodities, making checkpoint 2.0 more important than ever for the leaders.

The speedy review comes as no great surprise. The FDA has deep experience in this field, and has helped hustle along new players. It also marks the agency’s 41st new drug OK for their list, with 3 months to shoot far past last year’s 46.


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