FDA Approved New Oncology Drugs

Revolutionizing Oncology Through FDA-Approved Breakthroughs

Drugs Approved in 2023

  • Brenzavvy (bexagliflozin); TheracosBio, LLC; To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise, Approved January 2023
  • Columvi (glofitamab-gxbm); Genentech; ​To treat diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy, Approved June 2023
  • Daybue (trofinetide); Acadia Pharmaceuticals Inc.; To treat Rett syndrome, Approved March 2023
  • Elfabrio (pegunigalsidase alfa-iwxj); Protalix BioTherapeutics, Inc.; To treat confirmed Fabry disease, Approved May 2023
  • Epkinly (epcoritamab-bysp); AbbVie Inc.; To treat relapsed or refractory diffuse large B-cell lymphoma (not otherwise specified) and high-grade B-cell lymphoma after two or more lines of systemic therapy, Approved May 2023
  • Filspari (sparsentan); Travere Therapeutics, Inc.; To reduce proteinuria in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression, Approved February 2023
  • Inpefa (sotagliflozin); Lexicon Pharmaceuticals, Inc.; ​To treat heart failure, Approved May 2023
  • Jaypirca (pirtobrutinib); Eli Lilly and Company; To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor, Approved January 2023
  • Jesduvroq (daprodustat); GlaxoSmithKline; To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months, Approved February 2023
  • Joenja (leniolisib); Pharming Group N.V.; To treat activated phosphoinositide 3-kinase delta syndrome, Approved March 2023
  • Lamzede (velmanase alfa-tycv); Chiesi Global Rare Diseases; To treat non-central nervous system manifestations of alpha-mannosidosis, Approved February 2023
  • Leqembi (lecanemab-irmb); Biogen Inc. and Eisai Co., Ltd.; To treat Alzheimer’s disease, Approved January 2023
  • Miebo (perfluorhexyloctane); Bausch + Lomb Corporation and Novaliq; To treat signs and symptoms of dry eye disease, Approved May 2023
  • Orserdu (elacestrant); Menarini Group; To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated, advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, Approved January 2023
  • Paxlovid (nirmatrelvir, ritonavir); Pfizer Inc.; To treat mild-to-moderate COVID-19 in adults at high risk for progression to severe COVID-19, Approved May 2023
  • Posluma (flotufolastat F 18); Blue Earth Diagnostics; To use with positron emission tomography imaging in certain patients with prostate cancer, Approved May 2023
  • Qalsody (tofersen); Biogen Inc.; To treat amyotrophic lateral sclerosis in adults who have a SOD1 gene mutation, Approved April 2023
  • Rezzayo (rezafungin); Cidara Therapeutics, Inc.; To treat candidemia and invasive candidiasis, Approved March 2023
  • Skyclarys (omaveloxolone); Reata Pharmaceuticals, Inc.; To treat Friedrich’s ataxia, Approved February 2023
  • Veozah (fezolinetant); Astellas Pharma Inc.; To treat moderate to severe hot flashes caused by menopause, Approved May 2023
  • Xacduro (sulbactam, durlobactam); Innoviva, Inc.; To treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex, Approved May 2023
  • Zavzpret (zavegepant); Pfizer Inc.; To treat migraine, Approved March 2023
  • Zynyz (retifanlimab-dlwr); Incyte; To treat metastatic or recurrent locally advanced Merkel cell carcinoma, Approved March 2023

Drugs Approved in 2022

  • Amvuttra (vutrisiran); Alnylam Pharmaceuticals, Inc.; To treat polyneuropathy of hereditary transthyretin-mediated amyloidosis, Approved June 2022
  • Briumvi (ublituximab-xiiy); TG Therapeutics, Inc.; To treat relapsing forms of multiple sclerosis, Approved December 2022
  • Camzyos (mavacamten); Bristol Myers Squibb; To treat certain classes of obstructive hypertrophic cardiomyopathy, Approved April 2022
  • Cibinqo (abrocitinib); Pfizer Inc.; To treat refractory, moderate-to-severe atopic dermatitis, Approved January 2022
  • Daxxify (daxibotulinumtoixnA-lanm); Revance Therapeutics, Inc.; To treat moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity, Approved September 2022
  • Elahere (mirvetuximab soravtansine-gynx); ImmunoGen, Inc.; To treat patients with recurrent ovarian cancer that is resistant to platinum therapy, Approved November 2022
  • Elucirem (gadopiclenol); Guerbet; To detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body, Approved September 2022
  • Enjaymo (sutimlimab-jome); Sanofi; To decrease the need for red blood cell transfusion due to hemolysis in cold agglutinin disease, Approved February 2022
  • Imjudo (tremelimumab); AstraZeneca; To treat unresectable hepatocellular carcinoma, Approved October 2022
  • Kimmtrak (tebentafusp-tebn); Immunocore; To treat unresectable or metastatic uveal melanoma, Approved January 2022
  • Krazati (adagrasib); Mirati Therapeutics, Inc.; To treat KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer in adults who have received at least one prior systemic therapy, Approved December 2022
  • Lunsumio (mosunetuzumab-axgb); Genentech; To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma, Approved December 2022
  • Lytgobi (futibatinib); Taiho Oncology, Inc.; To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements, Approved September 2022
  • Mounjaro (tirzepatide); Eli Lilly and Company; To improve blood sugar control in diabetes, in addition to diet and exercise, Approved May 2022
  • NexoBrid (anacaulase-bcdb); MediWound Ltd.; To remove eschar in adults with deep partial thickness or full thickness thermal burns, Approved December 2022
  • Omlonti (oomidenepag isopropyl ophthalmic solution); Santen Inc.; To reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension, Approved September 2022
  • Opdualag (nivolumab and relatlimab-rmbw); Bristol Myers Squibb; To treat unresectable or metastatic melanoma, Approved March 2022
  • Pluvicto (lutetium (177Lu) vipivotide tetraxetan); Novartis; To treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies, Approved March 2022
  • Pyrukynd (mitapivat); Agios Pharmaceuticals, Inc.; To treat hemolytic anemia in pyruvate kinase deficiency, Approved February 2022
  • Quviviq (daridorexant); Idorsia Ltd.; To treat insomnia, Approved January 2022
  • Relyvrio (sodium phenylbutyrate/taurursodiol); Amylyx Pharmaceuticals, Inc.; To treat amyotrophic lateral sclerosis (ALS), Approved September 2022
  • Rezlidhia (olutasidenib); Forma Therapeutics; To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, Approved December 2022
  • Rolvedon (eflapegrastim); Spectrum Pharmaceuticals, Inc.; To decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia, Approved September 2022
  • Sotyktu (deucravacitinib); Bristol Myers Squibb; To treat moderate-to-severe plaque psoriasis, Approved September 2022
  • Spevigo (spesolimab-sbzo); Boehringer Ingelheim; To treat generalized pustular psoriasis flares, Approved September 2022
  • Sunlenca (lenacapavir); Gilead Sciences, Inc.; To treat adults with HIV whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations, Approved December 2022
  • Tecvayli (teclistamab-cqyv); Janssen Pharmaceutical Companies of Johnson & Johnson; To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy, Approved October 2022
  • Terlivaz (terlipressin); Mallinckrodt plc; To improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function, Approved September 2022
  • Tzield (teplizumab-mzwv); Provention Bio, Inc.; To delay the onset of stage 3 type 1 diabetes, Approved November 2022
  • Vabysmo (faricimab-svoa); Genentech; To treat neovascular (wet) aged-related macular degeneration and diabetic macular edema, Approved January 2022
  • Vivjoa (oteseconazole); Mycovia Pharmaceuticals, Inc.; To reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are not of reproductive potential, Approved April 2022
  • Vonjo (pacritinib); CTI BioPharma Corp.; To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets, Approved February 2022
  • Voquezna (vonoprazan, amoxicillin, and clarithromycin); Phathom Pharmaceuticals, Inc.; To treat Helicobacter pylori infection, Approved May 2022
  • Vtama (tapinarof); Dermavant Sciences; To treat plaque psoriasis, Approved May 2022
  • Xenoview (hyperpolarized Xe-129); Polarean Imaging plc; To evaluate pulmonary function and imaging, Approved December 2022
  • Xenpozyme (Olipudase alfa); Sanofi; To treat Acid Sphingomyelinase Deficiency, Approved August 2022
  • Ztalmy (ganaxolone); Marinus Pharmaceuticals, Inc.; To treat seizures in cyclin-dependent kinase-like 5 deficiency disorder, Approved March 2022

Drugs Approved in 2021

  • Adbry (tralokinumab-ldrm); LEO Pharma A/S; To treat moderate-to-severe atopic dermatitis, Approved December 2021
  • Aduhelm (aducanumab-avwa); Blueprint Medicines; To treat Alzheimer’s disease, Approved June 2021
  • Amondys 45 (casimersen); Sarepta Therapeutics, Inc.; To treat Duchenne muscular dystrophy, Approved February 2021
  • Azstarys (serdexmethylphenidate and dexmethylphenidate); Corium, Inc; To treat attention deficit hyperactivity disorder, Approved March 2021
  • Besremi (ropeginterferon alfa-2b-njft); PharmaEssentia Corporation; To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells, Approved November 2021
  • Brexafemme (ibrexafungerp ); SCYNEXIS, Inc.; To treat vulvovaginal candidiasis, Approved June 2021
  • Bylvay (odevixibat); Albireo Pharma, Inc.; To treat pruritus, Approved July 2021
  • Cabenuva (cabotegravir and rilpivirine (co-packaged); ViiV Healthcare; To treat HIV, Approved January 2021
  • Cosela (trilacicilib); G1 Therapeutics, Inc.; To mitigate chemotherapy-induced myelosuppression in small cell lung cancer, Approved February 2021
  • Cytalux  (pafolacianine); Grand River Aseptic Manufacturing; To help identify ovarian cancer lesions , Approved November 2021
  • Empaveli (pegcetacoplan); Apellis Pharmaceuticals, Inc.; To treat paroxysmal nocturnal hemoglobinuria, Approved May 2021
  • Evkeeza (evinacumab-dgnb); Regeneron Pharmaceuticals, Inc.; To treat homozygous familial hypercholesterolemia, Approved February 2021
  • Exkivity (mobocertinib); Takeda Pharmaceuticals America, Inc.; To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, Approved September 2021
  • Fexinidazole (fexinidazole); Sanofi-Aventis U.S. LLC; To treat human African trypanosomiasis caused by the parasite Trypanosoma brucei gambiense, Approved July 2021
  • Fotivda (tivozanib); AVEO Pharmaceuticals, Inc.; To treat renal cell carcinoma, Approved March 2021
  • Jemperli (dostarlimab-gxly); GlaxoSmithKline LLC; To treat endometrial cancer, Approved April 2021
  • Kerendia (finerenone); Bayer Healthcare Pharmaceuticals Inc.; To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes, Approved July 2021
  • Korsuva (difelikefalin); Vifor (International) Inc.; To treat moderate-to-severe pruritus associated with chronic kidney disease in certain populations, Approved August 2021
  • Leqvio (inclisiran); Novartis Pharmaceuticals Corporation; To treat heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease as an add-on therapy, Approved December 2021
  • Livmarli (maralixibat); Mirum Pharmaceuticals Inc.; To treat cholestatic pruritus associated with Alagille syndrome, Approved September 2021
  • Livtencity (maribavir); Takeda Pharmaceuticals America, Inc.; To treat post-transplant cytomegalovirus (CMV) infection/disease that does not respond (with or without genetic mutations that cause resistance) to available antiviral treatment for CMV, Approved November 2021
  • Lumakras (sotorasib); To treat types of non-small cell lung cancer, Approved May 2021
  • Lupkynis (voclosporin); Aurinia Pharma U.S., Inc.; To treat lupus nephritis, Approved January 2021
  • Lybalvi (olanzapine and samidorphan); Alkermes, Inc.; To treat schizophrenia and certain aspects of bipolar I disorder , Approved May 2021
  • Nextstellis (drospirenone and estetrol); Mayne Pharma; To prevent pregnancy, Approved April 2021
  • Nexviazyme (avalglucosidase alfa-ngpt); Genzyme Corporation; To treat late-onset Pompe disease, Approved August 2021
  • Nulibry (fosdenopterin); Origin Biosciences, Inc.; To reduce the risk of mortality in molybdenum cofactor deficiency Type A, Approved February 2021
  • Pepaxto (melphalan flufenamide); Oncopeptides, AB; To treat relapsed or refractory multiple myeloma, Approved February 2021
  • Ponvory (ponesimod); Janssen Pharmaceuticals, Inc; To treat relapsing forms of multiple sclerosis, Approved March 2021
  • Pylarify (piflufolastat F 18 ); Progenics Pharmaceuticals, Inc.; To identify prostate-specific membrane antigen-positive lesions in prostate cancer, Approved May 2021
  • Qelbree (viloxazine); Supernus Pharmaceuticals, Inc; To treat attention deficit hyperactivity disorder, Approved April 2021
  • Qulipta (atogepant); AbbVie Inc.; To prevent episodic migraines, Approved September 2021
  • Rezurock (belumosudil); Kadmon Pharmaceuticals, LLC; To treat chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy, Approved July 2021
  • Rybrevant (amivantamab-vmjw); Janssen Biotech, Inc.; To treat a subset of non-small cell lung cancer, Approved May 2021
  • Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn); Jazz Pharmaceuticals, Inc.; To treat acute lymphoblastic leukemia and lymphoblastic lymphoma in patients who are allergic to E. coli-derived asparaginase products, as a component of a chemotherapy regimen, Approved June 2021
  • Saphnelo (anifrolumab-fnia); AstraZeneca Pharmaceuticals LP; To treat moderate-to severe systemic lupus erythematousus along with standard therapy, Approved July 2021
  • Scemblix (asciminib); Novartis Pharmaceuticals Corporation; To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria, Approved October 2021
  • Skytrofa (lonapegsomatropin-tcgd ); Ascendis Pharma Endocrinology, Inc.; To treat short stature due to inadequate secretion of endogenous growth hormone, Approved August 2021
  • Tavneos (avacopan); ChemoCentryx, Inc.; To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) in combination with standard therapy, including glucocorticoids, Approved October 2021
  • Tepmetko (tepotinib); EMD Serono, Inc.; To treat non-small cell lung cancer, Approved February 2021
  • Tezspire (tezepelumab-ekko); Amgen, Inc; To treat severe asthma as an add-on maintenance therapy, Approved December 2021
  • Tivdak (tisotumab vedotin-tftv); Seagen Inc.; To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, Approved September 2021
  • Truseltiq (infigratinib); QED Therapeutics, Inc.; To treat cholangiocarcinoma whose disease meets certain criteria, Approved May 2021
  • Ukoniq (umbralisib); TG Therapeutics, Inc.; To treat marginal zone lymphoma and follicular lymphoma, Approved February 2021
  • Verquvo (vericiguat); Merck Sharp & Dohme LLC; To mitigate the risk of cardiovascular death and hospitalization for chronic heart failure, Approved January 2021
  • Voxzogo (vosoritide); BioMarin Pharmaceutical Inc.; To improve growth in children five years of age and older with achondroplasia and open epiphyses, Approved November 2021
  • Vyvgart (efgartigimod alfa-fcab); Argenx US; To treat generalized myasthenia gravis, Approved December 2021
  • Welireg (belzutifan); Merck Sharp & Dohme LLC; To treat von Hippel-Lindau disease under certain conditions, Approved August 2021
  • Zegalogue (dasiglucagon); Zealand Pharma US, Inc; To treat severe hypoglycemia, Approved March 2021
  • Zynlonta (loncastuximab tesirine-lpyl); ADC Therapeutics America, Inc.; To treat certain types of relapsed or refractory large B-cell lymphoma, Approved April 2021
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