J&J receives fifth FDA nod for treating multiple myeloma, with boxed warning and REMS in tow

John­son & John­son’s Janssen has re­ceived its fifth drug ap­proval for mul­ti­ple myelo­ma, se­cur­ing an ac­cel­er­at­ed nod for its bis­pe­cif­ic Talvey on Thurs­day morn­ing.

The FDA cleared the an­ti­body, known in­ves­ti­ga­tion­al­ly as tal­que­tam­ab, for adults with re­lapsed or re­frac­to­ry mul­ti­ple myelo­ma af­ter four or more pri­or treat­ment at­tempts. Talvey will be­come avail­able with­in three weeks, a spokesper­son told End­points News via email. The list price is $45,000 per month or a range of $270,000 to $360,000, de­pend­ing on treat­ment du­ra­tion. In clin­i­cal stud­ies, pa­tients were typ­i­cal­ly on treat­ment for about six to eight months, the spokesper­son said, not­ing J&J ex­pects Medicare and most com­mer­cial in­sur­ance plans to cov­er Talvey.

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