The European Medicines Agency (EMA) has granted priority medicines (PRIME) eligibility for bb2121 to treat patients with relapsed and refractory multiple myeloma.
The treatment has also received breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA).
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Developed by US-based biotechnology firms Celgene and bluebird bio, bb2121 is a chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) in previously treated patients with multiple myeloma.
Celgene Global Regulatory Affairs chief medical officer and head Dr Jay Backstrom said: “Receiving breakthrough therapy designation and PRIME eligibility for bb2121 further underscores the potential of this novel cellular immunotherapy approach to multiple myeloma treatment.
“We will work closely with these agencies as we accelerate development of bb2121, a novel technology and therapy for patients with multiple myeloma.”
Both breakthrough therapy designation and PRIME eligibility for bb2121 were based on the preliminary clinical data obtained from the ongoing Phase I CRB-401 study.
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By GlobalDatabluebird bio chief medical officer Dr David Davidson said: “Despite recent advances, multiple myeloma remains an incurable disease, and heavily pre-treated patients have limited therapeutic options.
“Early data suggest that treatment with bb2121 has the potential to induce durable responses in this patient population. It is encouraging for both the FDA and EMA to identify bb2121 as a candidate for accelerated development as we continue our work with Celgene to bring this therapy to patients in need of new options.”
The FDA BTD is to expedite the development and review of drugs that can be potentially used to treat serious or life-threatening conditions.
PRIME eligibility is a programme launched by the EMA to increase support for the development of medicines that target an unmet medical requirement.
