Mer­ck eats the lunch Bris­tol My­ers nev­er served, win­ning TMB-based OK for Keytru­da

Bris­tol My­ers Squibb might have pop­u­lar­ized the con­cept of us­ing tu­mor mu­ta­tion­al bur­den to iden­ti­fy pa­tients most like­ly to ben­e­fit from check­point in­hibitors, but Mer­ck’s ever dom­i­nant Keytru­da is claim­ing the first ap­proval based on the bio­mark­er.

The OK for un­re­sectable or metasta­t­ic TMB-high sol­id tu­mors — de­fined as 10 mu­ta­tions per megabase or more — is the sec­ond bio­mark­er-based in­di­ca­tion for Keytru­da that cov­ers tu­mors that fit the bill re­gard­less of where in the body they orig­i­nate.

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