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FDA Breakthrough Therapy Designation: Fourth Drug Receives FDA Approval

February 18, 2014

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The FDA approves on February 12, the fourth drug to have the coveted Breakthrough Therapy Designation (BTD). The approval is for orphan drug Imbruvica (Ibrutinib) as a single agent for the treatment of patients with Chronic Lymphocytic Leukemia (CLL) who have received at least one prior therapy. Imbruvica, a once-daily, oral kinase inhibitor, is developed and commercialized by Pharmacyclics and Janssen Biotech. Imbruvica is the :

•   1st FDA BTD drug to receive approval in 2014

•   1st FDA BTD drug to receive approval for a 2nd indication – Mantle Cell Lymphoma (MCL) on 11.13.13

•   2nd FDA BTD drug to receive approval for the same indication, Chronic Lymphocytic Leukemia (CLL) – Genentech’s Gazyva (Obinutuzumab) receives approval for CLL on 11.01.13

•   3rd FDA BTD drug to receive approval for an oncology indication

•   4th FDA BTD drug to receive approval.

The media, investors, patients, regulatory agencies, and the pharmaceutical industry are watching closely those drugs that receive the FDA BTD to see what impact if any, the new coveted FDA Designation has on the amount of time it takes to receive FDA approval. The debate is ongoing since President Obama’s signing of FDASIA (FDA Safety and Innovation Act), in July 2012. It will be interesting to see :

•   If the FDA approves additional BTD drugs in 2014

•   What therapeutic category (i.e. oncology) receives the majority of FDA BTD approvals

•   The time to FDA approval from the time of the FDA BTD.

Ibrutinib’s 6 FDA ODDs

Row Num

Designation Date

Orphan   Designation

1

10-23-2013 Diffuse Large B-Cell Lymphoma

2

10-15-2013 Waldenstrom’s Macroglobulinemia

3

12-03-2012 Mantle Cell Lymphoma

4

04-06-2012 Chronic Lymphocytic Leukemia

5

05-30-2013 Small Lymphocytic Lymphoma

6

05-16-2013 Multiple Myeloma

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Ibrutinib’s 3 FDA BTDs

Row Num

Drug Name

Indication

1

Ibrutinib Relapsed Or Refractory Mantle Cell Lymphoma (MCL)

2

Ibrutinib Waldenstrom’s Macroglobulinemia

3

Ibrutinib Chronic or Small Lymphocytic Leukemia (CLL/SLL)

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References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “DNA Purification” Courtesy of Dr. Bruce Chassey Laboratory. National Institute Of Dental Research. Li-shan. NCI [Public domain in the US].

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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