FDA ap­proves J&J's BC­MA-tar­get­ed bis­pe­cif­ic for mul­ti­ple myelo­ma

The FDA on Tues­day grant­ed ac­cel­er­at­ed ap­proval to John­son & John­son’s Tec­vayli (teclis­tam­ab), a BC­MA-di­rect­ed bis­pe­cif­ic an­ti­body, look­ing to head in­to an al­ready crowd­ed field of treat­ments aim­ing to help those with the blood can­cer mul­ti­ple myelo­ma.

The ap­proval, which in­clud­ed a REMS due the risks of CRS and neu­ro­log­ic tox­i­c­i­ty, fol­lows promis­ing ear­ly ef­fi­ca­cy in 40 pa­tients, with 65% of pa­tients hav­ing a par­tial re­sponse or bet­ter, and fur­ther da­ta from a Phase I/II tri­al, pub­lished in the New Eng­land Jour­nal of Med­i­cine ear­li­er this month, known as Ma­jesTEC-1. Those re­sults showed that in a larg­er group of 165 pa­tients, with me­di­an fol­low-up of 14.1 months (range of 0.3 to 24.4), re­spons­es oc­curred in 104 pa­tients (63%; 95% con­fi­dence in­ter­val [CI], 55.2 to 70.4), as well as a par­tial re­sponse or bet­ter in 97 pa­tients (58.8%), and a com­plete re­sponse or bet­ter in 65 (39.4%).

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