The FDA has granted breakthrough therapy designation to Regeneron and Sanofi for cemiplimab, just a month after announcing they will part ways soon.
Cemiplimab (REGN2810) has been granted breakthrough therapy designation by the FDA for the treatment of metastatic cutaneous squamous cell carcinoma (CSCC), considered the second deadliest skin cancer after melanoma. The antibody is a PD-1 checkpoint inhibitor and blockbuster material given it has the same target as MSD’s Keytruda and BMS’ Opdivo.
Cemiplimab has already passed Phase I successfully and a Phase II trial is now enrolling the first patient. With breakthrough therapy designation, the application to the FDA for approval, which is expected in the first quarter of 2018, will receive priority review to accelerate the approval of the drug.
However, the good news comes just a month after Regeneron announced its agreement with Sanofi will end in December, without another extension. And without a word from Sanofi or an explanation, despite the success of the team so far with the approval of Praluent, Kevzara and Duxipent. Though the team will keep working together in the programs already in the pipeline, no new antibodies will come from the partnership anymore.
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