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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

[4]

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

Drug Manufacturer Indication
Elbasvir/grazoprevir Merck Hepatitis C
Palbociclib Pfizer HR-positive, HER2-negative breast cancer
Crizotinib PF Prism ROS-1-positive NSCLC
Venetoclax AbbVie CLL with 17p deletion
Cabozantinib Exelixis renal cell carcinoma
Pimavanserin Acadia Pharmaceuticals Parkinson's disease-related psychosis
Lenvatinib mesylate Eisai renal cell carcinoma
Nivolumab Bristol-Myers Squibb Hodgkin lymphoma
Atezolizumab Genentech urothelial carcinoma
Lumacaftor/ivacaftor Vertex Pharmaceuticals cystic fibrosis with CFTR F508del
Canakinumab Novartis Familial mediterranean fever
Canakinumab Novartis Hyper-IgD syndrome
Canakinumab Novartis TNF receptor associated periodic syndrome
Atezolizumab Genentech metastatic NSCLC
Olaratumab Eli Lilly soft tissue sarcoma
Pembrolizumab Merck metastatic NSCLC
Nivolumab Bristol-Myers Squibb head and neck cancer
Daratumumab Janssen multiple myeloma
Oliceridine Trevena Analgesia and pain management
Rucaparib Clovis Oncology BRCA-mutated ovarian cancer
Silver diamine fluoride Elevate Oral Care Early childhood caries


2015

Drug Manufacturer Indication
Ibrutinib Pharmacyclics Waldenstrom’s macroglobulinemia
Palbociclib Pfizer ER-positive, HER2-negative breast cancer
Ranibizumab Genentech Diabetic retinopathy
ivacaftor Vertex Pharmaceuticals cystic fibrosis with a variety of CFTR mutations
Aflibercept Regeneron Pharmaceuticals diabetic retinopathy
Sirolimus PF Prism lymphangioleiomyomatosis
Lumacaftor/ivacaftor Vertex Pharmaceuticals cystic fibrosis with CFTR F508del mutation
Ombitasvir/paritaprevir/ritonavir AbbVie Hepatitis C
Uridine triacetate Wellstat hereditary orotic aciduria
Pembrolizumab Merck PDL-1 positive NSCLC
Nivolumab Bristol-Myers Squibb metastatic NSCLC
Idarucizumab Boehringer Ingelheim reversal of dabigatran
Asfotase alfa Alexion perinatal/infantile/childhood hypophosphatasia
Osimertinib AstraZeneca EGFR-positive NSCLC
Daratumumab Janssen multiple myeloma
Nivolumab Bristol-Myers Squibb advanced renal cell carcinoma
Elotuzumab Bristol-Myers Squibb multiple myeloma
Sebelipase alfa Synageva lysosomal acid lipase deficiency
Alectinib Roche ALK-mutated NSCLC
Pembrolizumab Merck metastatic melanoma
Ibalizumab TaiMed Biologics HIV-1 infection


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

  1. ^ "FDA Grants Psilocybin Second Breakthrough Therapy Designation". Medscape. Retrieved 5 January 2020.
  2. ^ "COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression". www.compasspathways.com. October 23, 2018. Retrieved April 2, 2019.
  3. ^ "FDA Puts 'Magic Mushroom' Ingredient on Fast Track for Depression Treatment". www.healthline.com. November 7, 2018. Retrieved April 2, 2019.
  4. ^ "Approval report" (PDF). www.fda.gov. Retrieved 2019-06-12.
  5. ^ "FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD". maps.org. August 26, 2017. Retrieved April 2, 2019.
  6. ^ "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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