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.

2013[edit]

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

2014[edit]

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[edit]

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[edit]

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[edit]

[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 Multidisciplinary Association for Psychedelic Studies Posttraumatic stress disorder


References[edit]