FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdomide With Priority Review

Bristol-Myers Squibb Company (NYSE:BMY) is one of the best value stocks to buy now. On February 17, Bristol Myers Squibb announced that the FDA accepted its NDA for iberdomide, which is an investigational treatment for patients with relapsed or refractory multiple myeloma/RRMM. If approved, iberdomide would become the first in a new class of oral medicines known as cereblon E3 ligase modulator agents. The FDA granted the application Priority Review and Breakthrough Therapy Designation, setting a target action date of August 17 this year.

The application is supported by data from the Phase 3 EXCALIBER-RRMM trial, which compared iberdomide in combination with daratumumab and dexamethasone against a standard three-drug regimen. A key highlight of this filing is the use of Minimal Residual Disease/MRD negativity as a primary endpoint. MRD measures the tiny number of cancer cells remaining in the body that traditional tests cannot find; achieving MRD negativity is a highly sensitive indicator that a treatment is effectively clearing the disease and may predict longer periods of remission.

Iberdomide works through targeted protein degradation, a process where the drug tags specific cancer-promoting proteins for destruction by the cell’s internal recycling system. This approach builds on Bristol-Myers Squibb Company’s (NYSE:BMY) long-standing history with immunomodulatory drugs, aiming to provide a more potent oral option with a manageable safety profile.

Bristol-Myers Squibb Company (NYSE:BMY) discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide.

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