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News From the Food and Drug Administration
November 7, 2017

Intravenous Lymphoma Drug Approved

JAMA. 2017;318(17):1644. doi:10.1001/jama.2017.16047

The FDA has granted accelerated approval to a new medication for adults with relapsed follicular lymphoma who’ve already received systemic therapy at least twice. Accelerated approvals allow drugs for serious conditions that fill an unmet medical need to be cleared for marketing based on a surrogate end point rather than measureable clinical benefit.

Copanlisib, which is marketed as Aliqopa, is an intravenous phosphatidylinositol-3-kinase (PI3K) inhibitor that blocks the PI3Kα and Pl3Kδ isoforms expressed in malignant B cells. Dysregulation of the Pl3K pathway, which is involved in cell growth, survival, and metabolism, plays an important role in follicular lymphoma.