Sanofi, Re­gen­eron earn ‘break­through’ sta­tus for a fast-track drug out to prove PD-1 dom­i­nance

Can an ex­per­i­men­tal PD-1 drug still of­fer break­through po­ten­tial?

The FDA to­day said yes, hand­ing out its break­through ther­a­py des­ig­na­tion for the new­ly dubbed cemi­plimab (REGN2810) from Re­gen­eron and its long­time Big Phar­ma part­ner Sanofi.

Reg­u­la­tors hand­ed out the ti­tle — good for open­ing doors at the FDA for de­vel­op­ment ex­ec­u­tives in a rush — in metasta­t­ic cu­ta­neous squa­mous cell car­ci­no­ma and adults with lo­cal­ly ad­vanced and un­re­sectable CSCC, the sec­ond dead­liest skin can­cer af­ter melanoma.

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