FDA Accepts NDA for Parsaclisib for Non-Hodgkin Lymphomas

The new drug application submission of parsaclisib (Incyte) was based on data from several phase 2 studies that evaluate the treatment.

The FDA has accepted a new drug application (NDA) for parsaclisib (Incyte), an oral inhibitor of phosphatidylinositol 3-kinase delta, to treat individuals with relapsed or refractory non-Hodgkin, such as follicular lymphoma, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL).

“Non-Hodgkin lymphomas [NHLs] are some of the most common cancers in the United States, and the FDA’s acceptance of this NDA represents an important milestone for Incyte and for NHL patients who have not responded to or who have progressed on initial therapies,” Peter Langmuir, MD, group vice president of Oncology Targeted Therapies at Incyte, said in a statement.

The submission was based on data from several phase 2 studies that evaluates parsaclisib as treatment for the NHLs and was generally well-tolerated in studies with a manageable safety profile. by the FDA for the treatment of adult individuals with relapsed or refractory MZL who received at least 1 prior anti-CD20-based regimen and for individuals with MCL who received 1 prior therapy.

The FDA grants priority review to medicine that would be significant improvements to the effectiveness or safety of the diagnosis, prevention, or treatment of serious conditions.

Reference

Incyte announces acceptance of NDA for parsaclisib for three types of relapsed or refractory Non-Hodgkin Lymphomas. BioSpace. News release. November 1, 2021. Accessed November 5, 2021. https://www.biospace.com/article/releases/incyte-announces-acceptance-of-nda-for-parsaclisib-for-three-types-of-relapsed-or-refractory-non-hodgkin-lymphomas/