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FDA Breakthrough Therapy Designation: Statistics And Approval Charts Updated (as of 09/08/14)

September 15, 2014

The CBER BTD #s are current as of 08/31/14 and the CDER BTD #s are current as of 09/05/14.

The changes are as follows :

•   The total # of FDA CDER + CBER BTD Requests received by the FDA remains the same at 217

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 61 to 62

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 118 to 120

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 38 to 35.

FDA CBER + CDER BTDs (as of 09/05/14)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-08/31/14) Total # of CDER Designations (07/09/12-09/05/14) Total # of CBER +   CDER BTD Designations (07/09/12-09/05/14)
Total # of BTD Requests Received 34 183 217
Total # of BTDs Granted 6 56 62
Total # of BTDs   Denied 26 94 120
Total # of BTDs   Pending 2 33 35

.

OBSERVATIONS

•   28.6 %    of the total # of BTD Requests Received results in the BTD being granted

•   55.3 % of the total # of BTD Requests Received results in the BTD being denied

•   16.1 % of the total # of BTD Requests Received results in the BTD pending.

.

FDA BTDs Receiving Approval (as of 09/08/14)

Drug Name FDA Approval Date Sponsor Company Indication
Gazyva   (Obinutuzumab) 11.01.13 Genentech Chronic Lymphocytic Leukemia (CLL)
Imbruvica   (Ibrutinib) 11.13.13 Pharmacyclics Mantle Cell Lymphoma (MCL)
Sovaldi   (Sofosbuvir) 12.06.13 Gilead   Sciences Hepatitis C
Kalydeco (Ivacaftor)** 02.21.14 Vertex Pharmaceuticals 8 additional mutations in CFTR gene for Cystic Fibrosis (CF)
Ofatumumab (Arzerra)*** 04.17.14 GlaxoSmithKline In combination with Chlorambucil for previously untreated Patients with CLL for whom fludarabine-based therapy is considered inappropriate
Zykadia (Ceritinib) 04.29.14 Novartis Metastatic ALK+ NSCLC
Zydelig (Idelalisib) 07.23.14 Gilead Sciences Chronic Lymphocytic Leukemia (CLL)
Imbruvica (Ibrutinib)* 07.28.14 Pharmacyclics Chronic Lymphocytic Leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion)
Promacta (Eltrombopag)** 08.26.14 GlaxoSmithKline Severe Aplastic Anemia (SAA) with insufficient response to Immunosupporessive Therapy (IST)
Keytruda (Pembrolizumab) 09.04.14 Merck Unresectable/ Metastatic Melanoma, disease progression, & have BRAF V600 mutation, following treatment with Yervoy & a BRAF inhibitor

* Expanded the approved use of Imbruvica (Ibrutinib) for CLL

**   Approval for a Supplemental New Drug Application (sNDA)

*** Approval for a Supplemental Biologic License Application (sBLA).

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

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

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