FDA Accepts NDA For Parsaclisib for Non-Hodgkin Lymphoma

The FDA will review parsaclisib as a treatment for Non-Hodgkin lymphoma (NHL) after accepting Incyte’s New Drug Application (NDA). Specifically, the NDA was submitted for the treatment of relapsed or refractory follicular lymphoma, mantle cell lymphoma, and marginal zone lymphoma.

Parsaclisib for NHL

Parsaclisib is an oral drug manufactured by Incyte for the treatment of certain NHLs. It is intended to help patients whose cancer has not responded to or progressed on prior therapies. It was evaluated in a number of phase 2 studies, such as CITADEL-203, CITADEL-204, and CITADEL-205. In fact, it was these studies that pushed the FDA to review the drug in the first place.

Alongside the accepted NDA, parsaclisib has also received priority review for two indications: adult patients with mantle cell lymphoma who have already been treated with one therapy, and adult patients with relapsed or refractory marginal zone lymphoma who have already been treated with a minimum of one anti-CD20—based therapy.

The FDA’s decisions are expected to be released in 2022. Specifically, they will decide on the marginal zone and mantle cell lymphoma indications by the end of April, 2022 and the follicular lymphoma indication by the end of August, 2o22.

About NHL

Non-Hodgkin lymphoma is a category of cancers that falls under the larger group of lymphomas. It originates in the lymphatic system, forming out of a type of white blood cell called lymphocytes. Medical professionals are unsure as to why exactly this cancer develops, but they have identified a number of risk factors. These include older age, interactions with certain chemicals, treatment with immunosuppressants, and certain viruses or infections. Regardless of cause, this cancer causes symptoms like:

  • Pain and swelling in the abdomen
  • Swelling in the lymph nodes in the groin, armpit, and neck
  • Coughing
  • Fatigue
  • Fever
  • Unexplained weight loss
  • Chest pain
  • Breathing issues
  • Night sweats

You can read more about parsaclisib here.

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