FDA Grants Accelerated Approval to BMS’s Zenbexus for Multiple Myeloma in Combination with Daratumumab

August 23, 2026

U.S. Food and Drug Administration (FDA) USA

Overview

The U.S. FDA has granted accelerated approval to Bristol Myers Squibb’s (BMS) Zenbexus (iberdomide), a novel CELMoD (cereblon E3 ligase modulator), for the treatment of multiple myeloma. This approval applies to patients who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, when Zenbexus is used in combination with daratumumab, hyaluronidase-fihj, and dexamethasone. The decision is based on compelling efficacy data from the pivotal EXCALIBER-RRMM trial, offering a new therapeutic option for this relapsed/refractory patient population.

In Depth

Key Findings

Bristol Myers Squibb (BMS) has secured accelerated approval from the U.S. Food and Drug Administration (FDA) for its novel cereblon E3 ligase modulator (CELMoD) Zenbexus (iberdomide) for the treatment of multiple myeloma. This marks Zenbexus as the first FDA-approved CELMoD therapy for multiple myeloma, specifically for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent, when used in combination with daratumumab, hyaluronidase-fihj, and dexamethasone.

Technical/Clinical Details

Zenbexus operates by selectively modulating cereblon, leading to the degradation of specific proteins crucial for multiple myeloma cell survival and proliferation. The accelerated approval is supported by data from the ongoing Phase 2 EXCALIBER-RRMM trial, which demonstrated a favorable overall response rate (ORR) and a manageable safety profile in patients treated with Zenbexus in combination with daratumumab and dexamethasone. This combination therapy offers a novel mechanism of action that addresses current therapeutic limitations, particularly for patients who have become resistant to previous treatments. CELMoDs represent a significant advancement in targeted protein degradation, providing a new class of agents that can reprogram cell function to combat cancer.

Background & Context

Multiple myeloma is an incurable hematological malignancy characterized by the uncontrolled proliferation of plasma cells, necessitating continuous development of new treatment modalities, especially for patients experiencing relapse or refractoriness to conventional therapies. The approval of Zenbexus underscores BMS’s leadership and commitment to advancing targeted protein degradation, a burgeoning field in oncology. This strategy not only expands treatment options but also holds the potential to overcome drug resistance mechanisms that plague current therapies. The FDA’s accelerated approval pathway is designed to expedite the availability of drugs that demonstrate the potential to provide significant therapeutic benefit over existing treatments for serious conditions.

Strategic Significance & Outlook

The accelerated approval of Zenbexus is a landmark achievement for multiple myeloma patients, offering a new beacon of hope, particularly for those whose disease has progressed despite prior treatments. This approval validates BMS’s robust CELMoD platform and its potential beyond this initial indication. Future prospects include the completion of the EXCALIBER-RRMM trial, which will provide confirmatory data, and further investigations into Zenbexus’s utility in earlier lines of therapy or in combination with other agents. This innovative therapy is poised to significantly impact the treatment landscape of multiple myeloma, potentially improving long-term outcomes and quality of life for a broad patient population.

Source: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone

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