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EMA grants marketing authorization to duvelisib monotherapy for R/R CLL or FL
By Claire Baker
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On June 9, 2021, it was announced that, in May 2021, the European Medicines Agency (EMA) granted marketing authorization to single-agent duvelisib for the treatment of patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or follicular lymphoma (FL).
The dual PI3K-δ and PI3K-γ inhibitor is now approved for the treatment of patients with the following:
- R/R CLL who have received ≥2 prior therapies
- FL that is refractory to ≥2 prior systemic therapies
This decision follows a positive opinion from the EMA Committee for Medicinal Products for Human Use (CHMP) in March 2021. Duvelisib was previously approved by the U.S. Food and Drug Administration (FDA) for patients with R/R FL and those with R/R CLL or small lymphocytic lymphoma.
- Secura Bio. COPIKTRA® (duvelisib) receives European Union marketing authorization for the treatment of relapsed or refractory CLL and refractory FL. https://www.prnewswire.com/news-releases/copiktra-duvelisib-receives-european-union-marketing-authorization-for-the-treatment-of-relapsed-or-refractory-cll-and-refractory-fl-301308685.html. Published June 9, 2021. Accessed June 10, 2021.
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