Keytru­da nabs an­oth­er pri­or­i­ty re­view; Quell ties up CAR pact with Han­nover Med­ical School

→ Add an­oth­er pri­or­i­ty re­view for Mer­ck’s Keytru­da. Un­like most FDA sub­mis­sions, this one comes not for a par­tic­u­lar can­cer type but for tu­mors with a par­tic­u­lar bio­mark­er, known as tu­mor mu­ta­tion­al bur­den-high, or TMB-H. These are tu­mors that mu­tate rapid­ly and which, some ev­i­dence sug­gests, are more sus­cep­ti­ble to check­point in­hibitors like Keytru­da. This would be the sec­ond such bio­mark­er-based ap­proval for can­cer, Mer­ck said, af­ter Keytru­da got ap­proval for tu­mors that are mi­crosatel­lite in­sta­bil­i­ty-high or are mis­match re­pair de­fi­cient. A PDU­FA date is set for June 16.

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