On February 18, 2026, the U.S. Food and Drug Administration accepted Bristol‑Myers Squibb’s New Drug Application for iberdomide in combination with daratumumab and dexamethasone (IberDd) for patients with relapsed or refractory multiple myeloma. The acceptance was granted under Breakthrough Therapy Designation and Priority Review, and the agency set a Prescription Drug User Fee Act (PDUFA) date of August 17, 2026.
Iberdomide is a cereblon E3 ligase modulator (CELMoD), the first drug in its class to reach this regulatory milestone. The combination therapy leverages the potent anti‑CD38 activity of daratumumab with the oral, manageable‑safety profile of iberdomide, offering a novel treatment option for a disease with limited options.
The regulatory approval removes a major hurdle for Bristol‑Myers Squibb’s growth strategy. In 2025, the company’s Growth Portfolio generated $26.4 billion in revenue, up 17% from the prior year, while its Legacy Portfolio declined 15%. Full‑year 2025 revenue of $48.2 billion was flat versus 2024, underscoring the need for new growth assets. The iberdomide acceptance supports the company’s plan to replace legacy revenue with high‑margin oncology products.
Cristian Massacesi, MD, executive vice president and chief medical officer, said, “The FDA’s acceptance of this application is a testament to the potential of iberdomide, in combination with anti‑CD38 monoclonal antibodies, as a novel, potent, oral treatment option, with a manageable safety profile, for patients with multiple myeloma.” He added, “Furthermore, our filing for iberdomide based on the MRD endpoint underscores our commitment to pioneering new ways of advancing life‑saving therapies for patients living with cancer.”
While the acceptance itself did not trigger an immediate market reaction, it represents a significant regulatory milestone that could accelerate the company’s ability to bring a first‑in‑class therapy to patients and strengthen its oncology pipeline. The event aligns with Bristol‑Myers Squibb’s broader strategy to shift from legacy products to growth assets, positioning the company for future revenue growth.
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