FDA Accepts NDA for Ibrutinib for Two Non-Hodgkin's Subtypes


Pharmacyclics, Inc. announced at the end of last week that the U.S. Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for filing for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL).

Back at the end of June, Pharmacyclics submitted a New Drug Application (NDA) for ibrutinib under section 505(b) of the Food, Drug & Cosmetic Act.

Pharmacyclics learned on 27 August that the FDA had completed their filing review and determined that the application is sufficiently complete to permit a substantive review.

Said Dr. Urte Gayko, Senior Vice President of Global Regulatory Affairs for Pharmacyclics:

We are very excited to have received the official FDA acceptance of our first NDA filing for ibrutinib. We look forward to continuing to work with the FDA as they complete their review of the ibrutinib application which includes the new Breakthrough Therapy Designation process.

Each year, about 16,000 new cases of CLL/SLL are diagnosed in the United States, while about 2,500 new cases of mantle cell lymphoma are diagnosed.

Source: WSJ

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