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Orphan Drugs: Pharmacyclics’ 2 New Designations For Cancer

February 8, 2015





Pharmacyclics, receives two new oncology FDA Orphan Drug Designations (ODDs) on February 5th:

·   Nodal Marginal Zone Lymphoma

·   Splenic Marginal Zone Lymphoma.

Pharmacyclics’ 2 New Oncology FDA ODD Database Records

Generic Name: Ibrutinib Ibrutinib
Trade Name: Imbruvica Imbruvica
Date Designated: 02.05.2015 02.05.2015
Orphan Designation: Splenic marginal zone lymphoma Nodal Marginal Zone Lymphoma
Orphan Designation Status: Designated Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication Not FDA Approved for Orphan Indication


Since 2012, Imbruvica has received from the FDA: 9 ODDs, several BTDs, and approval for 4 oncology indications.

Pharmacyclics’ FDA Regulatory History For Imbruvica

Row Num Generic Name FDA ODD Designation Date FDA Approval Date FDA Breakthrough Therapy Designation  (BTD) Indication
1 Ibrutinib 05-30-2013 Small lymphocytic lymphoma
2 Ibrutinib 02-05-2015 Splenic marginal zone lymphoma
3 Ibrutinib 12-03-2012 11.13.2013 X Mantle cell lymphoma (MCL) with at least 1 prior therapy
4 Ibrutinib 10-23-2013 Diffuse large B-cell lymphoma
5 Ibrutinib 05-16-2013 Multiple myeloma
6 Ibrutinib 10-15-2013 01.29.15 X Waldenstrom’s macroglobulinemia (WM)
7 Ibrutinib 09-08-2014 Follicular lymphoma
8 Ibrutinib 04-06-2012 02.12.14/ 07.28.14 X Chronic lymphocytic leukemia (CLL) with at least 1 prior therapy/ CLL with 17p deletion
9 Ibrutinib 02-05-2015 Nodal marginal zone lymphoma

Please Note:Imbruvica” courtesy of Janssen Photo Gallery.

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