The FDA has accepted Bristol Myers Squibb’s New Drug Application for iberdomide, an oral therapy for relapsed/refractory multiple myeloma. This drug, a first-in-class cereblon E3 ligase modulator (CELMoD) agent, received priority review and breakthrough therapy designation. Its approval could significantly impact targeted protein degradation and oral oncology treatments, with its development also focusing on minimal residual disease negativity as a primary endpoint in clinical trials.
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FDA Accepts Bristol Myers Squibb's Iberdomide for Relapsed/Refractory Multiple Myeloma
The FDA has accepted Bristol Myers Squibb’s New Drug Application for iberdomide, an oral therapy for relapsed/refractory multiple myeloma. This drug, a first-in-class cereblon E3 ligase modulator (CELMoD) agent, received priority review and breakthrough therapy designation. Its approval could significantly impact targeted protein degradation and oral oncology treatments, with its development also focusing on minimal residual disease negativity as a primary endpoint in clinical trials.