FDA approves iberdomide (Bristol Myers Squibb, NYSE: BMY) for relapsed/refractory multiple myeloma by PDUFA date August 17, 2026
The PDUFA date for iberdomide (combination with daratumumab + dexamethasone, EXCALIBER-RRMM Phase 3 study) is August 17, 2026. BMS received both Breakthrough Therapy and Priority Review designation – both signals of strong regulatory support. The FDA historically approves ~83–87% of applications reaching a PDUFA date; with Breakthrough Therapy designation the rate is even higher (>90%). No negative Advisory Committee signal is known. Cassandra estimates the approval probability at 78% (slight discount vs historical average for a complex combination therapy).
78%