FDA Grants Priority Review to Parsaclisib for Relapsed/Refractory Non-Hodgkin Lymphoma
Parsaclisib has been granted a priority review for 3 indications that include relapsed or refractory follicular, marginal zone, and mantle cell lymphoma.
The FDA has granted a priority review to a new drug application (NDA) for parsaclisib to treat patients with relapsed or refractory follicular lymphoma (FL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL), according to a press release from Incyte.
Parsaclisib is an oral inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ). Under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to make a decision by April 30, 2022.
Multiple phase 2 studies in the ongoing CITADEL (Clinical Investigation of TArgeted PI3K-DELta Inhibition in Lymphomas) program, evaluating parsaclisib in adult lymphomas, supported the priority review.
CITADEL-203 (NCT03126019) is assessing parsaclisib in adults with relapsed or refractory FL lymphoma and have already received at least 2 prior systematic therapies and are not eligible for hematopoietic stem cell transplantation (HSCT). Patients also needed an Eastern Cooperative Oncology Group performance status (ECOG PS) ≤2,
CITADEL-204 (NCT03144674) is assessing parsaclisib in adults with relapsed or refractory MZL who were pretreated with at least 1 prior systemic therapy and were Bruton’s tyrosine kinase (BTK) inhibitor-treatment naïve. Initially, patients with prior ibrutinib (Imbruvica) treatment were eligible to participate, but because enrollment was scarce, the cohort was terminated.
Eligible participants included patients with radiologically measurable lymphadenopathy or extranodal lymphoid malignancy or histologically confirmed bone marrow infiltration in cases of splenic MZL and an ECOG PS ≤2.
The CITADEL-205 trial (NCT03235544) is assessing adults with relapsed of refractory MCL, who have already received 3 prior systematic therapies and were either treatment naïve or had previously received a BTK inhibitor. The participants needed to have an ECOG PS ≤2, radiologicallymeasurable lymphadenopathy or extranodal lymphoid malignancy, to be eligible.
Enrolled participants in each of these trials received parsaclisib 20 mg once daily for 8 weeks, followed by either 20 mg once weekly or 2.5 mg once daily. Ultimately, daily dosing was designated as the preferred regimen and the weekly-dosing group was allowed to switch to daily dosing. Prophylaxis was administered for Pneumocystis jirovecii pneumonia (PJP).
"Non-Hodgkin lymphomas 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 [non-Hodgkin lymphoma] patients who have not responded to or who have progressed on initial therapies," said Peter Langmuir, MD, group vice president of oncology and targeted therapies, Incyte, in the release. "We look forward to working with the FDA to bring this innovative therapy to patients who may benefit."
Incyte Announces Acceptance of NDA for Parsaclisib for Three Types of Relapsed or Refractory Non-Hodgkin Lymphomas. Business wire. News release. November 1, 2021. Accessed November 1, 2021. https://www.businesswire.com/news/home/20211101005269/en/