The FDA has accepted Bristol Myers Squibb’s New Drug Application for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. The drug has been granted Breakthrough Therapy Designation and Priority Review, with a target action date of August 17, 2026. This application is based on data from the Phase 3 EXCALIBER-RRMM study.
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FDA accepts Bristol Myers Squibb’s new drug application for iberdomide
The FDA has accepted Bristol Myers Squibb’s New Drug Application for iberdomide in combination with daratumumab and dexamethasone for patients with relapsed or refractory multiple myeloma. The drug has been granted Breakthrough Therapy Designation and Priority Review, with a target action date of August 17, 2026. This application is based on data from the Phase 3 EXCALIBER-RRMM study.