Bristol Myers’ subcutaneous version of Opdivo gets earlier PDUFA date

The FDA has short­ened the time­line for com­ing to a de­ci­sion on Bris­tol My­ers Squibb’s sub­cu­ta­neous ver­sion of its block­buster PD-1 in­hibitor Op­di­vo.

The com­pa­ny an­nounced Tues­day that the ther­a­py’s new PDU­FA date is Dec. 29, 2024, moved up from Feb. 28, 2025. If the FDA ap­proves sub­cu­ta­neous Op­di­vo, it would be avail­able in all of the sol­id tu­mors that the IV ver­sion is al­ready ap­proved in as a monother­a­py, monother­a­py main­te­nance fol­low­ing the com­ple­tion of Op­di­vo plus Yer­voy, or in com­bi­na­tion with chemother­a­py or cabozan­ti­nib, the com­pa­ny said.

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