FDA grants priority review to parsaclisib for two lymphoma indications
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The FDA granted priority review to parsaclisib for two lymphoma indications.
The designations apply to use of the agent for treatment of adults with relapsed or refractory marginal zone lymphoma who received at least one prior anti-CD-20-based regimen, as well as adults with mantle cell lymphoma who received at least one prior therapy.
The agency also will conduct a standard review of the agent for treatment of adults with relapsed or refractory follicular lymphoma who received at least two prior systemic therapies.
Parsaclisib (Incyte) is a novel oral inhibitor of the phosphatidylinositol 3-kinase delta.
Several phase 2 studies are underway to evaluate the drug as treatment for non-Hodgkin lymphoma — including follicular, marginal zone and mantle cell lymphomas — as well as autoimmune hemolytic anemia.
The lymphoma studies showed parsaclisib exhibited a manageable safety profile and appeared generally well-tolerated.
“Non-Hodgkin lymphomas are some of the most common cancers in the United States, and the FDA’s acceptance of this [new drug application] represents an important milestone for Incyte and for [patients with NHL] who have not responded to or who have progressed on initial therapies,” Peter Langmuir, MD, group vice president for oncology targeted therapies at Incyte, said in a company-issued press release. “We look forward to working with the FDA to bring this innovative therapy to patients who may benefit.”
The FDA is expected to make a decision on approval of the marginal zone and mantle cell lymphoma indications by April 30, 2022. The agency is expected to make a decision on the follicular lymphoma indication by Aug. 30, 2022.
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