Merck’s Welireg wins label expansion in kidney cancer despite missing survival data

Mer­ck’s Welireg won a la­bel ex­pan­sion on Thurs­day in a com­mon form of kid­ney can­cer, weeks ahead of its de­ci­sion date and with­out a clear over­all sur­vival (OS) ben­e­fit.

The drug, belzu­ti­fan, will now be avail­able to pa­tients with ad­vanced re­nal cell car­ci­no­ma who’ve al­ready tried a PD-1 or PD-L1 in­hibitor and a VEGF-TKI in­hibitor. Mer­ck touts Welireg as the first in its class for these ad­vanced pa­tients, who com­prise about 15% of new di­ag­noses, ac­cord­ing to the com­pa­ny. The list price is $28,248 for a 30-day sup­ply.

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