FDA has granted accelerated approval to Bristol Myers Squibb’s Zenbexus, or iberdomide, in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy.
The regimen, known as ZDd, is approved for patients whose previous treatment included a proteasome inhibitor and an immunomodulatory agent. The decision allows use of the combination as early as first relapse in eligible adults with relapsed or refractory disease.
Zenbexus is the first FDA-approved cereblon E3 ligase modulator, or CELMoD, for multiple myeloma. CELMoDs are a class of medicines designed to target proteins involved in the growth and survival of myeloma cells.
The accelerated approval was based on results from the Phase 3 EXCALIBER-RRMM trial, which compared ZDd with daratumumab, bortezomib and dexamethasone, or DVd, in adults with relapsed or refractory multiple myeloma who had received one or two prior lines of therapy.
At a median follow-up of 16 months, 41% of patients treated with ZDd achieved a minimal residual disease-negative complete response at any time, compared with 21% of patients receiving DVd. The difference was statistically significant, according to Bristol Myers Squibb.
The FDA’s decision represents the first approval in relapsed or refractory multiple myeloma based on minimal residual disease-negative complete response, the company said. Minimal residual disease negativity refers to the absence of detectable cancer cells using sensitive testing methods.
The approval was granted under FDA’s accelerated approval pathway. Continued approval may depend on verification and description of clinical benefit in confirmatory studies. Zenbexus received Breakthrough Therapy designation, and the application was reviewed through FDA’s Project Orbis program, which permits concurrent review by regulatory authorities in several countries.
Zenbexus is taken orally at a recommended dose of 1 mg once daily on days 1 through 21 of each 28-day treatment cycle, in combination with daratumumab and hyaluronidase-fihj and dexamethasone. Treatment continues until disease progression or unacceptable toxicity.
The drug carries boxed warnings for embryo-fetal toxicity and venous and arterial thromboembolism.
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