FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Near­ly three years af­ter okay­ing the CAR-Ts Yescar­ta and Kym­ri­ah, the FDA has ap­proved a new CD19 ther­a­py.

Mor­phoSys’ Mon­ju­vi, or taf­a­sita­m­ab-cx­ix, was cleared Fri­day for use in re­frac­to­ry dif­fuse large B-cell lym­phoma (DBLCL). The ap­proval sets up both Mor­phoSys and their com­mer­cial part­ner In­cyte to com­pete with Gilead and No­var­tis in the ul­tra-com­pet­i­tive in­di­ca­tion, where sim­i­lar tri­al re­sults and far eas­i­er de­liv­ery could al­low them to cut a fair share of the mar­ket.

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