List of drugs granted breakthrough therapy designation
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This is a list of drugs which granted breakthrough therapy designation by years:
Drugs may be listed more than once, as breakthrough designation is awarded individually for each indication.
2019
Drug | Manufacturer | Indication |
---|---|---|
Psilocybin | Usona Institute | Major depressive disorder[1] |
2018
Drug | Manufacturer | Indication |
---|---|---|
Psilocybin | COMPASS Pathways | Treatment resistant depression[2][3] |
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 NSCLC |
Durvalumab | AstraZeneca | metastatic urothelial carcinoma |
Kisqali-Femara Co-pack | Novartis | breast cancer |
Ribaxamase | Synthetic Biologics | antibiotic resistance / c. diff |
Midomafetamine (Ecstasy) | Multidisciplinary Association for Psychedelic Studies | Posttraumatic stress disorder[5][6] |
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.
- ^ "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.
- ^ "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.