FDA Breakthrough Therapy Designation Approval Chart
The Total FDA BTD Approval Chart is divided into 2 charts:
• FDA CBER BTDs Receiving Approval
• FDA CDER BTDs Receiving Approval.
FDA CBER BTDs Receiving Approval (as of 01/31/15)
The FDA CBER Breakthrough Therapy Designations receiving approval (as of 01/31/15), in ascending chronological “FDA Approval Date” order, are as follows:
| Drug Name | FDA Approval Date | Sponsor Company | Indication |
| Trumenba (Meningococcal Group B Vaccine) ***** | 10.29.14 | Pfizer | Meningococcal B Disease |
| Bexsero (Meningococcal Group B Vaccine) ***** | 01.23.15 | Novartis | Meningococcal B Disease |
***** Accelerated Approval
FDA CDER BTDs Receiving Approval (as of 03/25/15)
The FDA CDER Breakthrough Therapy Designations receiving approval (as of 03/25/15), in ascending chronological “FDA Approval Date” order, are as follows:
| 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) |
| Arzerra (Ofatumumab) *** | 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 |
| Harvoni (Ledipasvir /Sofosbuvir) | 10.10.14 | Gilead Sciences | Genotype 1 Chronic HCV |
| Esbriet (Pirfenidone) | 10.15.14 | InterMune | Idiopathic Pulmonary Fibrosis |
| Ofev (Nintedanib) | 10.15.14 | Boehringer Ingelheim Pharmaceuticals | Idiopathic Pulmonary Fibrosis |
| Blincyto (Blinatumomab) | 12.03.14 | Amgen | Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL) |
| Viekira Pak (Ombitasvir, Paritaprevir, Ritonavir) | 12.19.14 | AbbVie | Chronic hepatitis C virus (HCV) genotype 1 |
| Opdivo (Nivolumab) | 12.22.14 | Bristol-Myers Squibb | Unresectable/ Metastatic Melanoma |
| Kalydeco (Ivacaftor) ** | 12.29.14 | Vertex Pharmaceuticals | Cystic Fibrosis Ages 6 & older who have the R117H Mutation |
| Imbruvica (Ibrutinib) * | 01.29.15 | Pharmacyclics | Waldenstrom’s Macroglobulinemia (WM) |
| Ibrance (Palbociclib) ***** | 02.03.15 | Pfizer | Postmenopausal women with ER+/HER2- advanced breast cancer, as initial endocrine-based therapy for metastatic disease |
| Lucentis (Ranibizumab Injection) * | 02.06.15 | Genentech | Diabetic Retinopathy (DR) with Diabetic Macular Edema (DME) |
| Kalydeco (Ivacaftor) * | 03.18.15 | Vertex Pharmaceuticals | Cystic Fibrosis Ages 2 to 5 who have 1 of 10 mutations in the CFTR gene |
| Eylea (Aflibercept Injection) * | 03.25.15 | Regeneron Pharmaceuticals | Diabetic Retinopathy (DR) with Diabetic Macular Edema (DME) |
* Expanded the approved use
** Approval for a Supplemental New Drug Application (sNDA)
*** Approval for a Supplemental Biologic License Application (sBLA)
**** Pembrolizumab formerly known as Lambrolizumab
***** Accelerated Approval
References
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