List_of_drugs_granted_breakthrough_therapy_designation

List of drugs granted breakthrough therapy designation

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Drugs granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA). Drugs may be listed more than once since breakthrough therapy can be awarded for multiple indications.

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This article uses material from the Wikipedia article List_of_drugs_granted_breakthrough_therapy_designation, and is written by contributors. Text is available under a CC BY-SA 4.0 International License; additional terms may apply. Images, videos and audio are available under their respective licenses.

[New_Drug_Therapy_Approvals_2023-1] [1]
New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024. This article incorporates text from this source, which is in the public domain.

[CDER_Breakthrough_Therapy-2] [2]
"CDER Breakthrough Therapy Designation Approvals Data as of December 31, 2022" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on December 8, 2019. Retrieved June 25, 2023. This article incorporates text from this source, which is in the public domain.

[Breakthrough_Therapy_Approvals-3] [3]
"Breakthrough Therapy Approvals". U.S. Food and Drug Administration (FDA). 2020-10-08. Archived from the original on 2023-06-11. Retrieved 2023-06-25.

[4] [4]
"FDA grants Breakthrough Therapy Designation for Roche's balovaptan in autism spectrum disorder". Roche. Retrieved 2024-04-08.

[5] [5]
"Approval report" (PDF). U.S. Food and Drug Administration (FDA). Archived (PDF) from the original on 2019-04-24. Retrieved 2019-06-12.

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Brand name	Manufacturer	Indication
Elrexfio		To treat relapsed or refractory multiple myeloma after at least four lines of therapy^[1]
Fabhalta		To treat paroxysmal nocturnal hemoglobinuria^[1]
Izervay		To treat geographic atrophy secondary to age-related macular degeneration^[1]
Leqembi		To treat Alzheimer's disease^[1]
Loqtorzi		To treat recurrent or metastatic nasopharyngeal carcinoma with or following other therapies^[1]
Ogsiveo		To treat desmoid tumors^[1]
Pombiliti		To treat late-onset Pompe disease with miglustat^[1]
Rivfloza		To lower urinary oxalate levels in primary hyperoxaluria type 1 and relatively preserved kidney function^[1]
Talvey		To treat relapsed or refractory multiple myeloma after at least four therapies^[1]

Drug	Manufacturer	Indication
Abrocitinib	Pfizer	atopic dermatitis
Tebentafusp	Immunocore	HLA-A*02:01–positive uveal melanoma
Sutimlimab	Bioverativ	cold agglutinin disease
Lutetium (177Lu) vipivotide tetraxetan	Novartis	prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC)
Alpelisib	Novartis	PIK3CA-related overgrowth spectrum conditions
Mavacamten	Myokardia Inc	class II-III obstructive hypertrophic cardiomyopathy
Trastuzumab deruxtecan	Daiichi Sankyo	granted for three indications: HER2-positive breast cancer with prior anti-HER2-based treatment; HER2 low (IHC 1+ or IHC 2+/ISH) breast cancer; and non-small cell lung cancer with an activating HER2 mutation
Dupilumab	Regeneron Pharmaceuticals	granted for two indications: eosinophilic esophagitis; and atopic dermatitis
Ivosidenib	Servier Pharmaceuticals	acute myeloid leukemia with a susceptible IDH1 mutation
Baricitinib	Eli Lilly and Co	severe alopecia areata
Setmelanotide	Rhythm Pharmaceuticals	Bardet–Biedl syndrome
Dextromethorphan/bupropion	Axsome Therapeutics	major depressive disorder
Pemigatinib	Incyte	myeloid/lymphoid neoplasms with FGFR1 rearrangement
Olipudase alfa	Genzyme	non–central nervous system manifestations of acid sphingomyelinase deficiency
Spesolimab	Boehringer Ingelheim	generalized pustular psoriasis
Futibatinib	Taiho Oncology	intrahepatic cholangiocarcinoma with FGFR2 gene fusions or other rearrangements
Teclistamab	Janssen	multiple myeloma
Teplizumab	Provention Bio	delay the onset of Stage 3 type 1 diabetes (T1D) in Stage 2 T1D
Atezolizumab	Genentech	alveolar soft part sarcoma
Adagrasib	Mirati Therapeutics	KRAS G12C-mutated non-small cell lung cancer
Mosunetuzumab	Genentech	follicular lymphoma
Lenacapavir	Gilead Sciences	HIV-1

Drug	Manufacturer	Indication
Crizotinib	PF Prism	ALK-positive systemic anaplastic large cell lymphoma
Trastuzumab deruxtecan	Daiichi Sankyo	HER2-positive gastric or gastroesophageal junction adenocarcinoma, previously treated with trastuzumab
Umbralisib	TG Therapeutics	marginal zone lymphoma, previously treated with an anti-CD20-based regimen
Evinacumab	Regeneron Pharmaceuticals	homozygous familial hypercholesterolemia
Trilaciclib	G1 Therapeutics	myelosuppression, when administered prior to a platinum/etoposide or topotecan containing regimen for small cell lung cancer
Fosdenopterin	Origin Biosciences	molybdenum cofactor deficiency, Type A
Tocilizumab	Genentech	systemic sclerosis-associated interstitial lung disease
Rilonacept	Kiniksa Pharmaceuticals	recurrent pericarditis
Dostarlimab	GSK	mismatch repair deficient recurrent or advanced endometrial cancer
Dapagliflozin	AstraZeneca	chronic kidney disease
Bupivacaine/meloxicam	Heron Therapeutics	postsurgical analgesia
Amivantamab	Janssen Biotech	non-small cell lung cancer with EGFR exon 20 insertion mutations
Sotorasib	Amgen	non-small cell lung cancer with KRAS G12C mutation
Avapritinib	Blueprint Medicines Corp	granted for two indications: mast cell leukemia and advanced systemic mastocytosis
Belumosudil	Kadmon Pharmaceuticals	chronic graft-versus-host disease
Pembrolizumab	Merck	high risk, early-stage triple-negative breast cancer
Avalglucosidase alfa	Genzyme	late-onset Pompe disease
Lenvatinib	Eisai Inc	advanced renal cell carcinoma, used in combination with pembrolizumab
Difelikefalin	Cara Therapeutics	pruritis related to hemodialysis in chronic kidney disease
Mobocertinib	Takeda Pharmaceuticals	non-small cell lung cancer with EGFR exon 20 insertion mutations
Cabozantinib	Exelixis	thyroid cancer
Maralixibat	Mirum Pharmaceuticals	cholestatic pruritus in Alagille syndrome
Asciminib	Novartis	granted for two indications: Philadelphia chromosome-positive chronic myeloid leukemia previously treated with tyrosine kinase inhibitors, and Philadelphia chromosome-positive chronic myeloid leukemia with T315I mutation
Sirolimus	AADI Bioscience	metastatic or unresectable perivascular epithelioid cell tumor
Maribavir	Takeda	refractory post-transplant cytomegalovirus infection
Abatacept	Bristol Myers Squibb	acute graft-versus-host disease, in combination with a calcineurin inhibitor and methotrexate, undergoing hematopoietic stem cell transplantation from a matched or 1 allele-mismatched unrelated donor
Voxelotor	Global Blood Therapeutics Inc	sickle cell disease
Cabotegravir	ViiV Healthcare Co	pre-exposure prophylaxis for HIV

Drug	Manufacturer	Indication
Avapritinib	Blueprint Medicines Corp	metastatic gastrointestinal stromal tumor
Teprotumumab-trbw	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 FGFR2 fusion
Sacituzumab govitecan-hziy	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
Pomalidomide	Celgene Corp	AIDS-related Kaposi sarcoma
Rucaparib	Clovis Oncology	metastatic castration-resistant prostate cancer
Ripretinib	Deciphera Pharmaceuticals	advanced gastrointestinal stromal tumor
Artesunate	Amivas LLC	severe malaria
Bevacizumab	Genentech	metastatic hepatocellular carcinoma
Atezolizumab	Genentech	metastatic hepatocellular carcinoma
Inebilizumab-cdon	Viela Bio	neuromyelitis optica spectrum disorder
Fostemsavir	Viiv Healthcare	multidrug-resistant HIV-1
Tafasitamab-cxix	MorphoSys	relapsed or refractory diffuse large B-cell lymphoma
Esketamine	Janssen	major depressive disorder with acute suicidal ideation or behavior^[2]
belantamab mafodotin-blmf	GlaxoSmithKline	refractory multiple myeloma
Satralizumab-mwge	Genentech	neuromyelitis optica spectrum disorder
Pralsetinib	Blueprint Medicines Corp	RET fusion-positive non-small cell lung cancer
Pitolisant	Harmony Biosciences	cataplexy in adults with narcolepsy^[2]
Atoltivimab/maftivimab/odesivimab-ebgn	Regeneron	Ebola Zaire
Lonafarnib	Eiger BioPharmaceuticals	Hutchinson-Gilford progeria syndrome (HGPS), processing-deficient progeroid laminopathies with LMNA or ZMPSTE24 mutations^[2]
Lumasiran	Alnylam Pharmaceuticals	primary hyperoxaluria type 1^[2]
Naxitamab-gqgk	Y-mAbs Therapeutics	relapsed or refractory high-risk neuroblastoma, used in combination with GM-CSF
Setmelanotide	Rhythm Pharmaceuticals	medical obesity caused by proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency
Pralsetinib	Blueprint Medicines Corp	RET-mutant medullary thyroid cancer or advanced or metastatic RET fusion-positive thyroid cancer, in radioactive iodine-refractory patients^[2]
Belimumab	GlaxoSmithKline	active lupus nephritis^[2]
Osimertinib	AstraZeneca	adjuvant therapy after tumor resection in non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations
Ansuvimab-zykl	Ridgeback Biotherapeutics	Ebola Zaire

Drug	Manufacturer	Indication
Letrozole/ribociclib^[2]	Novartis Pharmaceuticals	HR-positive, HER2-negative advanced or metastatic breast cancer^[2]
Esketamine	Janssen	treatment-resistant depression^[2]
Dupilumab	Regeneron Pharmaceuticals	atopic dermatitis^[2]
Brexanolone	Sage Therapeutics	postpartum depression^[2]
Palbociclib	Pfizer	metastatic breast cancer^[2]
Erdafitinib	Janssen	urothelial carcinoma^[2]
Pembrolizumab	Merck Sharp & Dohme	advanced renal cell carcinoma^[2]
Ado-trastuzumab emtansine	Genentech	HER2-positive early breast cancer^[2]
Tafamidis meglumine	Foldrx Pharmaceuticals	cardiomyopathy^[2]
Avelumab	EMD Serono	advanced renal cell carcinoma^[2]
Venetoclax	AbbVie	chronic lymphocytic leukemiaor small lymphocytic lymphoma^[2]
Galcanezumab	Eli Lilly	episodic cluster headache^[2]
Polatuzumab vedotin-piiq	Genentech	diffuse large B-cell lymphoma^[2]
Pexidartinib	Daiichi Sankyo	tenosynovial giant cell tumor^[2]
Entrectinib	Genentech	solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion^[2]
Pembrolizumab	Merck	endometrial carcinoma^[2]
Lenvatinib	Eisai	endometrial carcinoma^[2]
Elexacaftor/tezacaftor/ivacaftor	Vertex Pharmaceuticals	cystic fibrosis^[2]
Zanubrutinib	BeiGene	mantle cell lymphoma^[2]
Crizanlizumab-tmca	Novartis	sickle cell disease^[2]
Givosiran	Alnylam Pharmaceuticals	acute hepatic porphyria^[2]
Acalabrutinib	AstraZeneca	relapsed or refractory chronic lymphocytic leukemia^[2]
Acalabrutinib	AstraZeneca	untreated chronic lymphocytic leukemia^[2]
Voxelotor	Global Blood Therapeutics	sickle cell disease^[2]
Enfortumab vedotin-ejfv	Astellas Pharma	metastatic urothelial carcinoma^[2]
Fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	HER2-positive breast cancer^[2]

List_of_drugs_granted_breakthrough_therapy_designation

List of drugs granted breakthrough therapy designation

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Drug	Manufacturer	Indication
Tezacaftor/ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis
Durvalumab^[2]	AstraZeneca UK	unresectable Stage III non-small cell lung cancer
Ibalizumab-uiyk^[2]	Theratechnologies	human immunodeficiency virus type 1 (HIV-1) infection
Brentuximab vedotin^[2]	Seattle Genetics	Hodgkin lymphoma
Ipilimumab^[2]	Bristol-Myers Squibb	renal cell carcinoma
Nivolumab^[2]	Bristol-Myers Squibb	renal cell carcinoma
Burosumab-twza^[2]	Kyowa Hakko Kirin	X-linked hypophosphatemia
Osimertinib^[2]	AstraZeneca	metastatic non-small cell lung cancer
Dabrafenib^[2]	Novartis Pharmaceuticals	melanoma with BRAF V600E or V600K mutations
Trametinib^[2]	Novartis Pharmaceuticals	melanoma with BRAF V600E or V600K mutations
Dabrafenib^[2]	Novartis Pharmaceuticals	anaplastic thyroid cancer with BRAF V600E mutation
Trametinib^[2]	Novartis Pharmaceuticals	anaplastic thyroid cancer with BRAF V600E mutation
Fingolimod^[2]	Novartis Pharmaceuticals	multiple sclerosis
Rituximab^[2]	Genentech	pemphigus vulgaris
Venetoclax^[2]	AbbVie	chronic lymphocytic leukemia
Pembrolizumab^[2]	Merck Sharp & Dohme	mediastinal large B-cell lymphoma
Ipilimumab^[2]	Bristol-Myers Squibb	metastatic colorectal cancer
Nivolumab^[2]	Bristol-Myers Squibb	metastatic colorectal cancer
Ribociclib^[2]	Novartis Pharmaceuticals	breast cancer
Tafenoquine^[2]	GlaxoSmithKline	Plasmodium vivax malaria
Iobenguane I 131^[2]	Progenics Pharmaceuticals	pheochromocytoma or paraganglioma
Lumacaftor/ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis
Mogamulizumab-kpkc^[2]	Kyowa Hakko Kirin	mycosis fungoides or Sézary syndrome
Patisiran^[2]	Alnylam Pharmaceuticals	hereditary transthyretin-mediated amyloidosis
Cenegermin-bkbj^[2]	Dompe Farmaceutici	neurotrophic keratitis
Lanadelumab-flyo^[2]	Takeda Pharmaceuticals	hereditary angioedema
Cemiplimab-rwlc^[2]	Regeneron Pharmaceuticals	cutaneous squamous cell carcinoma
Amikacin liposome inhalation suspension^[2]	Insmed	mycobacterial lung disease
Emicizumab-kxwh^[2]	Genentech	hemophilia
Lorlatinib^[2]	Pfizer	ALK-positive, metastatic non-small cell lung cancer
Brentuximab vedotin^[2]	Seattle Genetics	anaplastic large-cell lymphoma
Eltrombopag^[2]	Novartis Pharmaceuticals	severe aplastic anemia
Emapalumab-lzsg^[2]	Swedish Orphan Biovitrum	hemophagocytic lymphohistiocytosis
Venetoclax^[2]	AbbVie	acute myeloid leukemia
Larotrectinib^[2]	Bayer Healthcare	solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Larotrectinib^[2]	Bayer Healthcare	solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
Amifampridine^[2]	Catalyst Pharmaceuticals	Lambert-Eaton myasthenic syndrome
Pembrolizumab^[2]	Merck Sharp & Dohme	Merkel cell carcinoma
Tagraxofusp-erzs^[2]	Stemline Therapeutics	blastic plasmacytoid dendritic cell neoplasm
Balovaptan^[4]	Roche	Autism spectrum

Drug	Manufacturer	Indication
Nivolumab^[2]	Bristol-Myers Squibb	urothelial carcinoma
Ribociclib^[2]	Novartis Pharmaceuticals	HR-positive, HER2-negative breast cancer
Pembrolizumab^[2]	Merck Sharp & Dohme	Hodgkin Lymphoma
Avelumab^[2]	EMD Serono	metastatic Merkel cell carcinoma
Niraparib^[2]	GlaxoSmithKline	recurrent ovarian cancer responsive to platinum-based chemotherapy
Ocrelizumab^[2]	Genentech	multiple sclerosis
Dupilumab^[2]	Regeneron Pharmaceuticals	atopic dermatitis
Palbociclib^[2]	Pfizer	HR-positive, HER2-negative breast cancer
Valbenazine^[2]	Neurocrine Biosciences	tardive dyskinesia
Ranibizumab^[2]	Genentech	diabetic retinopathy
Cerliponase alfa^[2]	BioMarin Pharmaceutical	tripeptidyl peptidase 1 (TPP1) deficiency
Midostaurin^[2]	Novartis Pharmaceuticals	FLT3-positive acute myeloid leukemia
Brigatinib^[2]	Takeda Pharmaceuticals	ALK-positive non-small cell lung cancer
Durvalumab^[2]	AstraZeneca UK	metastatic urothelial carcinoma
Letrozole/ribociclib^[2]	Novartis Pharmaceuticals	breast cancer
Pembrolizumab^[2]	Merck Sharp & Dohme	urothelial carcinoma
Tocilizumab^[2]	Genentech	giant cell arteritis
Pembrolizumab^[2]	Merck Sharp & Dohme	microsatellite instability-high tumors
Ceritinib^[2]	Novartis Pharmaceuticals	ALK-positive, metastatic non-small cell lung cancer
Dabrafenib^[2]	Novartis Pharmaceuticals	metastatic non-small cell lung cancer with BRAF V600E mutation
Trametinib^[2]	Novartis Pharmaceuticals	metastatic non-small cell lung cancer with BRAF V600E mutation
Ibrutinib^[2]	Pharmacyclics	chronic graft-versus-host disease
Glecaprevir/pibrentasvir^[2]	AbbVie	hepatitis C
Cytarabine/daunorubicin^[2]	Celator Pharmaceuticals	acute myeloid leukemia
Inotuzumab ozogamicin^[2]	Wyeth Pharmaceuticals	B-cell precursor acute lymphoblastic leukemia
Deutetrabenazine^[2]	Teva Pharmaceuticals	tardive dyskinesia
Abemaciclib^[2]	Eli Lilly	breast cancer
Acalabrutinib^[2]	AstraZeneca UK	mantle cell lymphoma
Vemurafenib^[2]	Hoffmann-La Roche	Erdheim-Chester disease with BRAF V600 mutation
Alectinib^[2]	Hoffmann-La Roche	ALK-positive, metastatic non-small cell lung cancer
Letermovir^[2]	Merck Sharp & Dohme	cytomegalovirus infection
Brentuximab vedotin^[2]	Seattle Genetics	anaplastic large-cell lymphoma
Emicizumab-kxwh^[2]	Genentech	hemophilia
Nivolumab^[2]	Bristol-Myers Squibb	melanoma

Drug	Manufacturer	Indication
Elbasvir/grazoprevir^[2]	Merck Sharp & Dohme	Hepatitis C
Palbociclib^[2]	Pfizer	HR-positive, HER2-negative breast cancer
Crizotinib^[2]	PF Prism	ROS1-positive NSCLC
Venetoclax^[2]	AbbVie	CLL with 17p deletion
Cabozantinib^[2]	Exelixis	renal cell carcinoma
Pimavanserin^[2]	Acadia Pharmaceuticals	Parkinson's disease-related psychosis
Ibrutinib^[2]	Pharmacyclics	small lymphocytic lymphoma (SLL) with 17p deletion
Lenvatinib^[2]	Eisai	renal cell carcinoma
Nivolumab^[2]	Bristol-Myers Squibb	Hodgkin lymphoma
Atezolizumab^[2]	Genentech	urothelial carcinoma
Sofosbuvir/velpatasvir^[2]	Gilead Sciences	chronic hepatitis C virus genotypes 1, 2, 3, 4, 5 or 6 infection
Canakinumab^[2]	Novartis	Familial mediterranean fever
Canakinumab^[2]	Novartis	Hyper-IgD syndrome
Canakinumab^[2]	Novartis	TNF receptor associated periodic syndrome
Lumacaftor/ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis with CFTR F508del
Atezolizumab^[2]	Genentech	metastatic NSCLC
Olaratumab^[2]	Eli Lilly	soft-tissue sarcoma
Nivolumab^[2]	Bristol-Myers Squibb	head and neck cancer
Daratumumab^[2]	Janssen	multiple myeloma
Rucaparib^[2]	Clovis Oncology	BRCA-mutated ovarian cancer

Drug	Manufacturer	Indication
Ibrutinib^[2]	Pharmacyclics	Waldenstrom’s macroglobulinemia
Palbociclib^[2]	Pfizer	ER-positive, HER2-negative breast cancer
Ranibizumab^[2]	Genentech	diabetic retinopathy
Ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis with a variety of CFTR mutations
Aflibercept^[2]	Regeneron Pharmaceuticals	diabetic retinopathy
Sirolimus^[2]	PF Prism	lymphangioleiomyomatosis
Sirolimus^[2]	PF Prism	lymphangioleiomyomatosis
Lumacaftor/ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis with CFTR F508del mutation
Ombitasvir/paritaprevir/ritonavir^[2]	AbbVie	Hepatitis C
Uridine triacetate^[2]	Wellstat Therapeutics	hereditary orotic aciduria
Pembrolizumab^[2]	Merck Sharp & Dohme	PDL-1 positive NSCLC
Nivolumab^[2]	Bristol-Myers Squibb	metastatic NSCLC
Idarucizumab^[2]	Boehringer Ingelheim	reversal of dabigatran
Asfotase alfa^[2]	Alexion Pharmaceuticals	perinatal/infantile/childhood hypophosphatasia
Osimertinib^[2]	AstraZeneca	EGFR-positive NSCLC
Daratumumab^[2]	Janssen Biotech	multiple myeloma
Nivolumab^[2]	Bristol-Myers Squibb	advanced renal cell carcinoma
Elotuzumab^[2]	Bristol-Myers Squibb	multiple myeloma
Sebelipase alfa^[2]	Alexion Pharmaceuticals	lysosomal acid lipase deficiency
Alectinib^[2]	Hoffmann-La Roche	ALK-mutated NSCLC
Pembrolizumab^[2]	Merck Sharp & Dohme	metastatic melanoma

Drug	Manufacturer	Indication
Ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis with CFTR mutation
Ofatumumab^[2]	Novartis Pharmaceuticals	chronic lymphocytic leukemia
Ceritinib^[2]	Novartis Pharmaceuticals	ALK-positive metastatic non-small cell lung cancer
Idelalisib^[2]	Gilead Sciences	relapsed chronic lymphocytic leukemia
Ibrutinib^[2]	Pharmacyclics	chronic lymphocytic leukemia (with 17p deletion
Eltrombopag^[2]	Novartis Pharmaceuticals	aplastic anemia
Pembrolizumab^[2]	Merck	metastatic melanoma
Ledipasvir/sofosbuvir^[2]	Gilead Sciences	Hepatitis C
Pirfenidone^[2]	Genentech	idiopathic pulmonary fibrosis
Nintedanib^[2]	Boehringer Ingelheim	idiopathic pulmonary fibrosis
Blinatumomab^[2]	Amgen	acute lymphoblastic leukemia
Ombitasvir/paritaprevir/ritonavir/dasabuvir^[2]	AbbVie	Hepatitis C
Nivolumab^[2]	Bristol-Myers Squibb^[2]	metastatic melanoma
Ivacaftor^[2]	Vertex Pharmaceuticals	cystic fibrosis with CFTR R117H mutation

Drug	Manufacturer	Indication
Obinutuzumab^[2]	Genentech	chronic lymphocytic leukemia
Ibrutinib^[2]	Pharmacyclics	mantle cell lymphoma
Sofosbuvir^[2]	Gilead Sciences	Hepatitis C