FDA accepts new drug application for parsaclisib for R/R FL, MZL, and MCL

Non-Hodgkin lymphomas (NHLs) are a varied group of lymphatic cancers that may be indolent or aggressive, and while some subtypes are more common than others, altogether, NHL is one of the most common cancers in the US. Types of NHL include B-cell lymphomas such as follicular lymphoma (FL) and marginal zone lymphoma (MZL), which generally have an indolent course, and the more aggressive mantle cell lymphoma (MCL). Regardless of the subtype, there remains an unmet need for treatment options for patients with relapsed or refractory (R/R) NHL.

Parsaclisib, an oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ), is currently being evaluated in several phase II clinical trials:

• CITADEL-203 (NCT03126019) is evaluating patients with Grade 1, 2, or 3a R/R FL who have received at least two prior systemic therapies and are ineligible for hematopoietic stem cell transplantation (HSCT).
• CITADEL-204 (NCT03144674) is evaluating patients with R/R MZL who have radiologically measurable disease, have received at least one prior systemic therapy, and are Bruton’s tyrosine kinase (BTK) inhibitor naïve.
• CITADEL-205 (NCT03235544) is evaluating patients with R/R MCL who have radiologically measurable disease, have received one to three prior lines of systemic therapy, and are either naïve to, or previously treated with, a BTK inhibitor.

Results of these studies showed that parsaclisib was well-tolerated in the study population with a manageable safety profile.

Based on the efficacy and safety data of parsaclisib from these clinical trials, the U.S. Food and Drug Administration (FDA) has now approved a new drug application (NDA) for parsaclisib to treat adult patients with R/R MZL, MCL, and FL. The FDA has also granted priority review for parsaclisib for the R/R MZL and MCL indications, while the NDA for parsaclisib in adult patients with R/R FL will have a standard review¹.