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