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词条 List of drugs granted breakthrough therapy designation
释义

  1. 2013

  2. 2014

  3. 2015

  4. 2016

  5. 2017

  6. 2018

  7. References

{{outofdate|date=March 2019}}

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.

2013

Drug Manufacturer Indication
Obinutuzumab Genentech Chronic lymphocytic leukemia
Ibrutinib Pharmacyclics Mantle cell lymphoma
Sofosbuvir Gilead Hepatitis C

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

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 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

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

2017

[1]
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 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[2][3]

2018

Drug Manufacturer Indication
Psilocybin Compass Pathways Treatment resistant depression[4][5]

References

1. ^https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/NDAandBLAApprovalReports/UCM494010.pdf
2. ^{{cite web |url=https://maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials |title= FDA Grants Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD |publisher= maps.org|access-date=April 2, 2019|date = August 26, 2017}}
3. ^{{cite web |url=https://www.nytimes.com/2018/05/01/us/ecstasy-molly-ptsd-mdma.html |title=Ecstasy as a Remedy for PTSD? You Probably Have Some Questions.|publisher= www.nytimes.com|access-date=April 2, 2019|date = May 1, 2018}}
4. ^{{cite web |url= https://compasspathways.com/compass-pathways-receives-fda-breakthrough-therapy-designation-for-psilocybin-therapy-for-treatment-resistant-depression/ |title= COMPASS Pathways Receives FDA Breakthrough Therapy Designation for Psilocybin Therapy for Treatment-resistant Depression |publisher= www.compasspathways.com |access-date=April 2, 2019|date = October 23, 2018}}
5. ^{{cite web |url= https://www.healthline.com/health-news/fda-looking-at-magic-mushroom-ingredient-to-treat-depression|title=FDA Puts ‘Magic Mushroom’ Ingredient on Fast Track for Depression Treatment|publisher= www.healthline.com |access-date=April 2, 2019|date = November 7, 2018}}

1 : Breakthrough therapy
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