Bris­tol-My­ers’ nivolum­ab grabs its sixth break­through des­ig­na­tion as new links to au­toim­mune dis­eases creep up

This morn­ing the FDA hand­ed out its 6th “break­through” drug des­ig­na­tion for Bris­tol-My­ers Squibb’s Op­di­vo (nivolum­ab), sig­nal­ing once again the agency will con­tin­ue to fa­cil­i­tate the check­point in­hibitor’s rapid roll­out in the on­col­o­gy mar­ket.

Check­point in­hi­bi­tion has be­come BMS’ spe­cial­ty, zip­ping ahead of Mer­ck’s Keytru­da (pem­brolizum­ab) in the PD-1 are­na as physi­cians glom on to this new treat­ment par­a­digm for or­ches­trat­ing an im­mune sys­tem as­sault on can­cer cells.

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