List of drugs granted breakthrough therapy designation
Below is a list of drugs granted breakthrough therapy designation (BTD) by the FDA.
Drugs may be listed more than once as BTD can be awarded for multiple indications.
2020
D-PLEX 100 || PolyPid Ltd|| Prevention of Surgical Site Infections (SSI)
2019
2018
2017
| Drug | Manufacturer | Indication |
|---|---|---|
| Nivolumab | Bristol-Myers Squibb | urothelial carcinoma |
| Ribociclib | Novartis | HR-positive, HER2-negative breast cancer |
| Pembrolizumab | Merck | Hodgkin Lymphoma |
| Avelumab | EMD Serono | metastatic Merkel cell carcinoma |
| Niraparib | Tesaro | recurrent ovarian cancer responsive to platinum-based chemotherapy |
| Ocrelizumab | Genentech | multiple sclerosis |
| Dupilumab | Regeneron Pharmaceuticals | atopic dermatitis |
| Palbociclib | Pfizer | HR-positive, HER2-negative breast cancer |
| Valbenazine | Neurocrine Biosciences | tardive dyskinesia |
| Cerliponase alpha | BioMarin | tripeptidyl peptidase 1 (TPP1) deficiency |
| Midostaurin | Novartis | FLT3-positive acute myeloid leukemia |
| Brigatinib | Ariad Pharmaceuticals | ALK-positive non-small cell lung cancer |
| Durvalumab | AstraZeneca | metastatic urothelial carcinoma |
| Kisqali-Femara Co-pack | Novartis | breast cancer |
| Ribaxamase | Synthetic Biologics | antibiotic resistance / Clostridioides difficile infection |
| Midomafetamine (Ecstasy) | Multidisciplinary Association for Psychedelic Studies | posttraumatic stress disorder[7][8] |
2016
2015
2014
| Drug | Manufacturer | Indication |
|---|---|---|
| Ivacaftor | Vertex Pharmaceuticals | cystic fibrosis with CFTR mutation |
| Ofatumumab | GlaxoSmithKline | chronic lymphocytic leukemia (CLL) |
| Ceritinib | Novartis | ALK-positive NSCLC |
| Idelalisib | Gilead | relapsed CLL |
| Ibrutinib | Pharmacyclics | CLL with 17p deletion |
| Eltrombopag | GlaxoSmithKline | aplastic anemia |
| Pembrolizumab | Merck | metastatic melanoma |
| Ledipasvir/sofosbuvir | Gilead | Hepatitis C |
| Nintedanib | Boehringer Ingelheim | idiopathic pulmonary fibrosis |
| Pirfenidone | Genentech | idiopathic pulmonary fibrosis |
| Blinatumomab | Amgen | acute lymphoblastic leukemia |
| Ombitasvir/paritaprevir/ritonavir | AbbVie | Hepatitis C |
| Nivolumab | Bristol-Myers Squibb | metastatic melanoma |
| Ivacaftor | Vertex Pharmaceuticals | cystic fibrosis with CFTR R117H mutation |
2013
| Drug | Manufacturer | Indication |
|---|---|---|
| Obinutuzumab | Genentech | chronic lymphocytic leukemia |
| Ibrutinib | Pharmacyclics | mantle cell lymphoma |
| Sofosbuvir | Gilead | Hepatitis C |
References
- "FDA Grants Psilocybin Second Breakthrough Therapy Designation". Medscape. Retrieved 5 January 2020.
- Research, Center for Drug Evaluation and (2020-10-08). "Breakthrough Therapy Approvals". FDA.
- "COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression". www.compasspathways.com. October 23, 2018. Retrieved April 2, 2019.
- "FDA Puts 'Magic Mushroom' Ingredient on Fast Track for Depression Treatment". www.healthline.com. November 7, 2018. Retrieved April 2, 2019.
- Research, Center for Drug Evaluation and (2020-10-08). "Breakthrough Therapy Approvals". FDA.
- "Approval report" (PDF). www.fda.gov. Retrieved 2019-06-12.
- "FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD". maps.org. August 26, 2017. Retrieved April 2, 2019.
- "Ecstasy as a Remedy for PTSD? You Probably Have Some Questions". www.nytimes.com. May 1, 2018. Retrieved April 2, 2019.
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