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Pharmaceuticals / Submissions and Approvals

EMA’s Priority Medicines Eligibility and FDA Breakthrough Therapy Designation Awarded to Juno and Celgene’s JCAR017

Jan. 4, 2017

The FDA granted a Breakthrough Therapy designation to JCAR017, developed by Juno Therapeutics and Celgene, for the treatment of patients with relapsed/refractory aggressive large B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, primary mediastinal b-cell lymphoma and grade 3b follicular lymphoma.

In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use and its Committee for Advanced Therapies granted JCAR017 access to its Priority Medicines scheme.

The drug is being developed for patients that do not respond to initial therapy or have relapsed disease, Juno said. The companies plan to initiate a trial in the U.S. next year. JCAR017 is not yet approved in any country.

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