Dr. Davids Discusses Duvelisib in Relapsed/Refractory CLL

Matthew S. Davids, MD, MMSc
Published: Tuesday, Jun 19, 2018



Matthew S. Davids, MD, MMSc, associate director, Center for Chronic Lymphocytic Leukemia, Dana-Farber Cancer Institute, discusses duvelisib in relapsed/refractory chronic lymphocytic leukemia (CLL).

In April 2018, the FDA granted a priority review to a new drug application (NDA) for duvelisib for patients with relapsed/refractory CLL and small lymphocytic lymphoma. The NDA was based on data from the phase III DUO trial and the phase II DYNAMO study. In the same NDA, the agent was also granted an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.

If duvelisib is approved, Davids says that it will be impactful in the relapsed/refractory patient population. In CLL, this is a population that has demonstrated benefit with newer drugs such as ibrutinib (Imbruvica) and venetoclax (Venclexta), but patients often progress.

Having a new FDA-approved PI3K inhibitor would be helpful, Davids says, particularly because it will most likely be approved as a monotherapy. This gives an option for an all-oral regimen for these patients, whereas the PI3K inhibitor idelalisib (Zydelig) is indicated for use in combination with rituximab (Rituxan).


Matthew S. Davids, MD, MMSc, associate director, Center for Chronic Lymphocytic Leukemia, Dana-Farber Cancer Institute, discusses duvelisib in relapsed/refractory chronic lymphocytic leukemia (CLL).

In April 2018, the FDA granted a priority review to a new drug application (NDA) for duvelisib for patients with relapsed/refractory CLL and small lymphocytic lymphoma. The NDA was based on data from the phase III DUO trial and the phase II DYNAMO study. In the same NDA, the agent was also granted an accelerated approval for the treatment of patients with relapsed/refractory follicular lymphoma.

If duvelisib is approved, Davids says that it will be impactful in the relapsed/refractory patient population. In CLL, this is a population that has demonstrated benefit with newer drugs such as ibrutinib (Imbruvica) and venetoclax (Venclexta), but patients often progress.

Having a new FDA-approved PI3K inhibitor would be helpful, Davids says, particularly because it will most likely be approved as a monotherapy. This gives an option for an all-oral regimen for these patients, whereas the PI3K inhibitor idelalisib (Zydelig) is indicated for use in combination with rituximab (Rituxan).



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