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Breakthrough therapy

List of drugs granted breakthrough therapy designation

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List of drugs granted breakthrough therapy designation

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Below is a list of drugs granted breakthrough therapy designation (BTD) by the Food and Drug Administration (FDA).

Drugs may be listed more than once as BTD can be awarded for multiple indications.

2020

Drug	Manufacturer	Indication
Avapritinib	Blueprint Medicines Corp	metastatic gastrointestinal stromal tumor
Tepezza	Horizon Therapeutics	thyroid eye disease
Nintedanib	Boehringer Ingelheim	chronic fibrosing interstitial lung diseases
Ipilimumab	Bristol-Myers Squibb	hepatocellular carcinoma
Nivolumab	Bristol-Myers Squibb	hepatocellular carcinoma
Selumetinib	AstraZeneca	neurofibromatosis type 1
Mitomycin	Urogen Pharma	upper tract urothelial cancer
Tucatinib	Seattle Genetics	advanced unresectable or metastatic HER2-positive breast cancer
Pemigatinib	Incyte Corp	metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion
Trodelvy	Immunomedics	metastatic triple-negative breast cancer
Capmatinib	Novartis	metastatic non-small cell lung cancer
Selpercatinib	Loxo Oncology	metastatic RET fusion-positive non-small cell lung cancer
Ripretinib	Deciphera Pharmaceuticals	advanced gastrointestinal stromal tumor
Artesunate	Amivas LLC	severe malaria
Bevacizumab	Genentech	metastatic hepatocellular carcinoma
Atezolizumab	Genentech	metastatic hepatocellular carcinoma
Inebilizumab	Viela Bio	neuromyelitis optica spectrum disorder
Fostemsavir	Viiv Healthcare Co	multidrug-resistant HIV-1
Monjuvi	MorphoSys	relapsed or refractory diffuse large B-cell lymphoma
Esketamine	Janssen	major depressive disorder with acute suicidal ideation or behavior
Blenrep	GlaxoSmithKline	refractory multiple myeloma
Enspryng	Genentech	neuromyelitis optica spectrum disorder
Pralsetinib	Blueprint Medicines Corp	RET fusion-positive non-small cell lung cancer

D-PLEX 100 || PolyPid Ltd|| Prevention of Surgical Site Infections (SSI)

2019

Drug	Manufacturer	Indication
Psilocybin	Usona Institute	major depressive disorder
B38M (JNJ‐4528)	Legend Biotech/Janssen	multiple myeloma
Rilonacept	Kiniska Pharmaceuticals	recurrent pericarditis
Inmazeb	Regeneron	Ebola Virus
Olorofim	F2G	invasive mold infections
Nintedanib	Boehringer Ingelheim	interstitial lung disease
Niraparib	Janssen	castration-resistant prostate cancer
Cobimetinib	Memorial Sloan Kettering	histiocytic neoplasms
Tepotinib	Merck	metastatic non-small cell lung cancer
Ansuvimab	Ridgeback Biotherapeutics	Ebola Virus
Capmatinib	Novartis	metastatic non-small cell lung cancer
Nirogacestat	SpringWorks Therapeutics	refractory desmoid tumors
Bempegaldesleukin	Nektar Therapeutics	melanoma
Peginterferon Lambda	Eiger BioPharmaceuticals	hepatitis delta virus infection
Acalabrutinib	AstraZeneca	chronic lymphocytic leukemia
Trilaciclib	G1 Therapeutics	small-cell lung cancer
Nedosiran	Dicerna Pharmaceuticals	primary hyperoxaluria
Pembrolizumab	Merck	hepatocellular carcinoma
Avexitide	Eiger BioPharmaceuticals	post-bariatric hypoglycemia
Copanlisib	Bayer	marginal zone lymphoma
LN-145	Iovance Biotherapeutics	cervical cancer
Trastuzumab deruxtecan	Daiichi Sankyo	HER2-positive breast cancer
SER-109	Seres Therapeutics	Clostridioides difficile infection
I.V. Artesunate	La Jolla Pharmaceutical	malaria
Elafibranor	Genfit	primary biliary cholangitis
Inebilizumab	Viela Bio	neuromyelitis optica spectrum disorder
Bentracimab	PhaseBio Pharmaceuticals	reversal agent for ticagrelor
Selumetinib	AstraZeneca/Merck	pediatric neurofibromatosis type 1
AXS-05	Axsome Therapeutics	major depressive disorder
ivosidenib	Agios Pharmaceuticals	acute myeloid leukemia
Venetoclax	Abbvie	chronic lymphocytic leukemia
AT-GAA	Amicus Therapeutics	Pompe disease
Pralsentinib	Blueprint Medicines	Non-small cell lung cancer
Seladelpar	CymaBay Therapeutics	primary biliary cholangitis
CP101	Finch Therapeutics	Clostridioides difficile infection
Nirsevimab	AstraZeneca	respiratory syncytial virus
Kadcyla	Genentech	HER2-positive breast cancer
Umbralisib	TG Therapeutics	marginal-zone lymphoma
V114	Merck	pneumococcal disease
Zanubrutinib	BeiGene USA	mantle cell lymphoma
Crizanlizumab	Novartis	sickle cell disease
Encorafenib	Array BioPharma	metastatic colorectal cancer

2018

Drug	Manufacturer	Indication
Tezacaftor/ivacaftor	Vertex Pharmaceuticals	cystic fibrosis
Durvalumab	AstraZeneca UK	unresectable Stage III non-small cell lung cancer (NSCLC)
Ibalizumab-uiyk	Theratechnologies	human immunodeficiency virus type 1 (HIV-1) infection
Brentuximab vedotin	Seattle Genetics	Hodgkin lymphoma
Ipilimumab	Bristol-Myers Squibb	renal cell carcinoma
Nivolumab	Bristol-Myers Squibb	renal cell carcinoma
Burosumab-twza	Kyowa Hakko Kirin	X-linked hypophosphatemia
Osimertinib	AstraZeneca	metastatic non-small cell lung cancer
Dabrafenib	Novartis Pharmaceuticals	melanoma with BRAF V600E or V600K mutations
Trametinib	Novartis Pharmaceuticals	melanoma with BRAF V600E or V600K mutations
Dabrafenib	Novartis Pharmaceuticals	anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Trametinib	Novartis Pharmaceuticals	anaplastic thyroid cancer (ATC) with BRAF V600E mutation
Fingolimod	Novartis Pharmaceuticals	multiple sclerosis
Rituximab	Genentech	pemphigus vulgaris
Venetoclax	AbbVie	chronic lymphocytic leukemia
Pembrolizumab	Merck Sharp & Dohme	mediastinal large B-cell lymphoma
Ipilimumab	Bristol-Myers Squibb	metastatic colorectal cancer
Nivolumab	Bristol-Myers Squibb	metastatic colorectal cancer
Ribociclib	Novartis Pharmaceuticals	breast cancer
Tafenoquine	GlaxoSmithKline	Plasmodium vivax malaria
Iobenguane i 131	Progenics Pharmaceuticals	pheochromocytoma or paraganglioma
Lumacaftor/ivacaftor	Vertex Pharmaceuticals	cystic fibrosis
Mogamulizumab-kpkc	Kyowa Hakko Kirin	mycosis fungoides (MF) or Sézary syndrome (SS)
Patisiran	Alnylam Pharmaceuticals	hereditary transthyretin-mediated amyloidosis
Cenegermin-bkbj	Dompe Farmaceutici	neurotrophic keratitis
Lanadelumab-flyo	Takeda Pharmaceuticals	hereditary angioedema
Cemiplimab-rwlc	Regeneron Pharmaceuticals	cutaneous squamous cell carcinoma
Amikacin liposome inhalation suspension	Insmed	mycobacterial lung disease
Emicizumab-kxwh	Genentech	hemophilia
Lorlatinib	Pfizer	anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer
Brentuximab vedotin	Seattle Genetics	anaplastic large-cell lymphoma
Eltrombopag	Novartis Pharmaceuticals	severe aplastic anemia
Emapalumab-lzsg	Swedish Orphan Biovitrum	hemophagocytic lymphohistiocytosis
Venetoclax	AbbVie	acute myeloid leukemia
Larotrectinib	Bayer Healthcare	solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Larotrectinib	Bayer Healthcare	solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Amifampridine	Catalyst Pharmaceuticals	Lambert-Eaton myasthenic syndrome
Pembrolizumab	Merck Sharp & Dohme	Merkel cell carcinoma
Tagraxofusp-erzs	Stemline Therapeutics	blastic plasmacytoid dendritic cell neoplasm
Psilocybin	COMPASS Pathways	treatment resistant depression
Satralizumab	Genentech	neuromyelitis optica spectrum disorder
Olipudase alfa	Sanofi/Genzyme	rare inherited disorders
Lonafarib	Eiger BioPharmaceuticals	Hutchinson-Gilford progeria syndrome
Eltrombopag	Novartis	thrombocytopenia
Galcanezumab	Eli Lilly	episodic cluster headache
NRX-101 (Cyclurad)	NRx Pharmaceuticals	bipolar depression with suicidal ideation
Mitomycin C	UroGen Pharma	urothelial cancer
Myrcludex	MYR Pharma	hepatitis delta
Belumosudil	Kadmon Holdings	graft-versus-host disease
Selpercatinib	Loxo Oncology	thyroid cancer
Selpercatinib	Loxo Oncology	Non-small cell lung cancer
Rucaparib	Clovis Oncology	castration-resistant prostate cancer
PF-06482077	Pfizer	pneumonia
Vocacapsaicin	Concentric Analgesics	pain relief
Tezepelumab	AstraZeneca/Amgen	asthma
Ritlecitinib	Pfizer	alopecia areata
Danyelza	Y-mAbs Therapeutics	neuroblastoma
Omalizumab	Genentech	severe allergic reactions
Encorafenib	Array BioPharma/Eli Lilly	colorectal cancer
Quizartinib	Daiichi Sankyo	acute myeloid leukemia
Pembrolizumab	Merck	endometrial carcinoma
Lenvatinib	Eisai	endometrial carcinoma
Bevacizumab	Genentech	hepatocellular carcinoma
Atezolizumab	Genentech	hepatocellular carcinoma
AMT-601	uniQure	hemophilia B
HTX-011	Heron Therapeutics	Postoperative Pain
Crizotinib	Pfizer	anaplastic large cell lymphoma
Crizotinib	Pfizer	small-cell lung cancer
Tafamidis meglumine	Foldrx Pharmaceuticals	cardiomyopathy
Lenti-D	Bluebird bio	cerebral adrenoleukodystrophy
Tafamidis	Pfizer	transthyretin cardiomyopathy
Pitolisant	Harmony Biosciences	narcolepsy
Trikafta	Vertex Pharmaceuticals	cystic fibrosis
Narsoplimab	Omeros Corporation	thrombotic microangiopathy
Trumenba	Pfizer	meningococcal disease
Esketamine	Johnson & Johnson	depression
Sodium thiosulfate	Fennec Pharmaceuticals	hepatoblastoma
Enfortumab vedotin	Astellas Pharma	metastatic urothelial carcinoma
Nesolicaftor	Proteostasis Therapeutics	cystic fibrosis
Erdafitinib	Janssen	urothelial carcinoma
Lumasiran	Alnylam Pharmaceuticals	primary hyperoxaluria
Sutimlimab	Bioverativ	cold agglutinin disease
Avasopasem manganese	Galera Therapeutics	oral mucositis
SPK-8011	Spark Therapeutics	hemophilia A
Abrocitinib	Pfizer	atopic dermatitis
Zuranolone	Sage Therapeutics	major depressive disorder
Fenfluramine	Zogenix	seizures associated with Dravet syndrome
Balovaptan	Hoffman-La Roche	autism spectrum disorder
Kisquali Femara Co-Pack	Novartis	HR-positive, HER2- negative breast cancer
Upadacitinib	AbbVie	atopic dermatitis
Lenvatinib + Pembrolizumab	Merck/Eisai	metastatic renal cell carcinoma
Voxelotor	Global Blood Therapeutics	sickle cell disease
Maribavir	Shire	Cytomegalovirus infection

2017

Drug	Manufacturer	Indication
Nivolumab	Bristol-Myers Squibb	urothelial carcinoma
Ribociclib	Novartis Pharmaceuticals	HR-positive, HER2-negative breast cancer
Pembrolizumab	Merck Sharp & Dohme	Hodgkin Lymphoma
Avelumab	EMD Serono	metastatic Merkel cell carcinoma
Niraparib	GlaxoSmithKline	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
Ranibizumab	Genentech	diabetic retinopathy
Cerliponase alfa	BioMarin Pharmaceutical	tripeptidyl peptidase 1 (TPP1) deficiency
Midostaurin	Novartis Pharmaceuticals	FLT3-positive acute myeloid leukemia
Brigatinib	Takeda Pharmaceuticals	ALK-positive non-small cell lung cancer
Durvalumab	AstraZeneca UK	metastatic urothelial carcinoma
Letrozole with Ribociclib	Novartis Pharmaceuticals	breast cancer
Pembrolizumab	Merck Sharp & Dohme	urothelial carcinoma
Tocilizumab	Genentech	giant cell arteritis
Pembrolizumab	Merck Sharp & Dohme	microsatellite instability-high tumors
Ceritinib	Novartis Pharmaceuticals	anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Dabrafenib	Novartis Pharmaceuticals	metastatic non-small cell lung cancer with BRAF V600E mutation
Trametinib	Novartis Pharmaceuticals	metastatic non-small cell lung cancer with BRAF V600E mutation
Ibrutinib	Pharmacyclics	chronic graft versus host disease (cGVHD)
Glecaprevir/pibrentasvir	AbbVie	hepatitis C
Cytarabine/daunorubicin	Celator Pharmaceuticals	acute myeloid leukemia
Inotuzumab ozogamicin	Wyeth Pharmaceuticals	B-cell precursor acute lymphoblastic leukemia
Deutetrabenazine	Teva Pharmaceuticals	tardive dyskinesia
Abemaciclib	Eli Lilly	breast cancer
Acalabrutinib	AstraZeneca UK	mantle cell lymphoma
Vemurafenib	Hoffmann-La Roche	Erdheim-Chester disease with BRAF V600 mutation
Alectinib	Hoffmann-La Roche	anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC)
Letermovir	Merck Sharp & Dohme	cytomegalovirus (CMV) infection
Letermovir	Merck Sharp & Dohme	cytomegalovirus (CMV) infection
Brentuximab vedotin	Seattle Genetics	anaplastic large-cell lymphoma
Emicizumab-kxwh	Genentech	hemophilia
Nivolumab	Bristol-Myers Squibb	melanoma
Ribaxamase	Synthetic Biologics	antibiotic resistance / Clostridioides difficile infection
Midomafetamine (Ecstasy)	Multidisciplinary Association for Psychedelic Studies	posttraumatic stress disorder

2016

Drug	Manufacturer	Indication
Elbasvir/grazoprevir	Merck Sharp & Dohme	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
Ibrutinib	Pharmacyclics	small lymphocytic lymphoma (SLL) with 17p deletion
Lenvatinib	Eisai	renal cell carcinoma
Nivolumab	Bristol-Myers Squibb	Hodgkin lymphoma
Atezolizumab	Genentech	urothelial carcinoma
Sofosbuvir/velpatasvir	Gilead Sciences	chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5 or 6 infection
Canakinumab	Novartis	Familial mediterranean fever
Canakinumab	Novartis	Hyper-IgD syndrome
Canakinumab	Novartis	TNF receptor associated periodic syndrome
Lumacaftor/ivacaftor	Vertex Pharmaceuticals	cystic fibrosis with CFTR F508del
Atezolizumab	Genentech	metastatic NSCLC
Olaratumab	Eli Lilly	soft-tissue sarcoma
Pembrolizumab	Merck Sharp & Dohme	metastatic NSCLC
Nivolumab	Bristol-Myers Squibb	head and neck cancer
Daratumumab	Janssen	multiple myeloma
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
Sirolimus	PF Prism	lymphangioleiomyomatosis
Lumacaftor/ivacaftor	Vertex Pharmaceuticals	cystic fibrosis with CFTR F508del mutation
Ombitasvir/paritaprevir/ritonavir	AbbVie	Hepatitis C
Uridine triacetate	Wellstat Therapeutics	hereditary orotic aciduria
Pembrolizumab	Merck Sharp & Dohme	PDL-1 positive NSCLC
Nivolumab	Bristol-Myers Squibb	metastatic NSCLC
Idarucizumab	Boehringer Ingelheim	reversal of dabigatran
Asfotase alfa	Alexion Pharmaceuticals	perinatal/infantile/childhood hypophosphatasia
Osimertinib	AstraZeneca	EGFR-positive NSCLC
Daratumumab	Janssen Biotech	multiple myeloma
Nivolumab	Bristol-Myers Squibb	advanced renal cell carcinoma
Elotuzumab	Bristol-Myers Squibb	multiple myeloma
Sebelipase alfa	Alexion Pharmaceuticals	lysosomal acid lipase deficiency
Alectinib	Hoffmann-La Roche	ALK-mutated NSCLC
Pembrolizumab	Merck Sharp & Dohme	metastatic melanoma
Ibalizumab	TaiMed Biologics	HIV-1 infection

2014

Drug	Manufacturer	Indication
Ivacaftor	Vertex Pharmaceuticals	cystic fibrosis with CFTR mutation
Ofatumumab	Novartis Pharmaceuticals	chronic lymphocytic leukemia (CLL)
Ceritinib	Novartis Pharmaceuticals	anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)
Idelalisib	Gilead Sciences	relapsed chronic lymphocytic leukemia (CLL)
Ibrutinib	Pharmacyclics	chronic lymphocytic leukemia (CLL) with 17p deletion
Eltrombopag	Novartis Pharmaceuticals	aplastic anemia
Pembrolizumab	Merck	metastatic melanoma
Ledipasvir/sofosbuvir	Gilead Sciences	Hepatitis C
Pirfenidone	Genentech	idiopathic pulmonary fibrosis
Nintedanib	Boehringer Ingelheim	idiopathic pulmonary fibrosis
Blinatumomab	Amgen	acute lymphoblastic leukemia
Ombitasvir/paritaprevir/ritonavir/dasabuvir	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 Sciences	Hepatitis C