The Food and Drug Administration will review parsaclisib for the treatment of patients with follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.
The Food and Drug Administration (FDA) accepted a new drug application for parsaclisib to treat patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma, according to Incyte, the manufacturer of the oral drug.
A new drug application is a formal request that a pharmaceutical company makes asking the FDA to review the medication in question. Once the FDA agrees to analyze a product, the agency will look at the drug’s safety and whether or not its benefits outweigh the risks; if the package insert included with the drug is appropriate and the important information it should contain; and if the methods of manufacturing the drug will ensure that the quality is maintained.
Parsaclisib was also granted a priority review for the treatment of adults with relapsed or refractory marginal zone lymphoma who had at least one previous anti-CD20—based therapy and for adults with mantle cell lymphoma who had one prior therapy. Priority reviews speed up the process by which the FDA reviews a drug.
The FDA will make its approval decision for the marginal zone lymphoma and mantle cell lymphoma indications by April 30, 2022. The agency will make its decision on parsaclisib for the treatment of relapsed or refractory follicular lymphoma after two prior systemic therapies by Aug. 30, 2022.
Last week, the FDA also granted a priority review to a CAR-T cell therapy for the treatment of follicular lymphoma.
"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 NHL patients who have not responded to or who have progressed on initial therapies," said Dr. Peter Langmuir, Group Vice President, Oncology Targeted Therapies, Incyte, in a statement.
The FDA agreed to review parsaclisib based on findings from multiple phase 2 studies: CITADEL-203, CITADEL-204 and CITADEL-205, which all showed that overall the drug was well-tolerated and had a manageable safety profile.
"We look forward to working with the FDA to bring this innovative therapy to patients who may benefit,” Langmuir said.
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