FDA Breakthrough and PRIME in EU status for lymphoma drug candidate

21 December 2016

The US Food and Drug Administration has granted Breakthrough Therapy designation to investigational drug JCAR017.

In addition, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) have granted JCAR017 access to the Priority Medicines (PRIME) scheme for r/r DLBCL.

JCAR017, under development by US biotech companies Juno Therapeutics (Nasdaq: JUNO) and Celgene (Nasdaq: CELG), is intended for the treatment of patients with relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (de novo or transformed from indolent lymphoma), primary mediastinal B-cell lymphoma (PMBCL) or Grade 3B follicular lymphoma.

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