Cancer: new FDA approvals
Brand, generic name, approval date and the use the FDA approved it for. No recommendations. Updated 2026-10-12.
Weight loss & diabetesCancerBrain & mental healthInfections & vaccinesHeart & bloodImmune & inflammatoryKidney, liver & lungEyeWomen's & hormonal healthPain & anesthesiaDiagnostic & imaging agentsRare & geneticOther
LyrfigtuCancer
lirafugratinibTo adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangementPixclaraCancer
floretyrosine F 18To use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change in conjunction with other diagnostic evaluationsEtcamahCancer
camizestrant · AstrazenecaTo treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapyRasonqueCancer
daraxonrasib · Revolution MedicinesTo treat metastatic pancreatic cancerZenbexusCancer
iberdomide · Bristol Myers SquibbTo be used in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agentJideytroCancer
zidesamtinib · NuvalentTo treat adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer after receiving a ROS1 kinase inhibitorRevtorpykCancer
gedatolisibIn combination with fulvestran, to treat hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic settingDecnupazCancer
pivekimab sunirine-pvzy · Abbvie Inc.To treat adults with blastic plasmacytoid dendritic cell neoplasmBeqalziCancer
sonrotoclaxTo treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitorVeppanuCancer
vepdegestrant · Rigel PharmsTo 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 therapyLifyorliCancer
relacorilant · Corcept TherapTo treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumabHyrnuoCancer
sevabertinibTo treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapyKomziftiCancer
ziftomenib · KuraTo treat adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment optionsInluriyoCancer
imlunestrantTo treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor-1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapyKeytruda QlexCancer
pembrolizumab and berahyaluronidase alfa-pmph · Merck Sharp DohmeTo treat adult and pediatric (12 years and older) solid tumor indications approved for the intravenous formulation of pembrolizumabHernexeosCancer
zongertinib · Boehringer IngelheimTo treat adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapyModeysoCancer
dordaviprone · ChimerixTo treat diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapyLynozyficCancer
linvoseltamab-gcptTo treat relapsed or refractory multiple myeloma after at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti CD38 monoclonal antibodyZegfrovyCancer
sunvozertinibTo treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, with disease progression on or after platinum-based chemotherapyIbtroziCancer
taletrectinibTo treat locally advanced or metastatic ROS1-positive non-small cell lung cancerEmrelisCancer
telisotuzumab vedotin-tllv · Abbvie Inc.To treat locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC) with high c-Met protein overexpression after prior systemic therapyAvmapki Fakzynja Co-PackCancer
avutometinib and defactinib · Verastem Inc.To treat KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) after prior systemic therapypenpulimab-kcqxCancer
penpulimab-kcqx · Akeso BiopharmaIn combination with either cisplatin or carboplatin and gemcitabine, to treat adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC), or as a single agent while on or after platinum-based chemotherapy and at least one other prior line of therapyRomvimzaCancer
vimseltinib · Deciphera PharmsTo treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidityGrafapexCancer
treosulfan · MedexusFor use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndromeDatrowayCancer
datopotamab deruxtecan-dlnk · Daiichi Sankyo Inc.To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic diseaseEnsacoveCancer
ensartinib · XcoveryTo treat non-small cell lung cancerUnloxcytCancer
cosibelimab-ipdlTo treat cutaneous squamous cell carcinomaBizengriCancer
zenocutuzumab-zbco · Merus N.V.To treat non-small cell lung cancer and pancreatic adenocarcinomaZiiheraCancer
zanidatamab-hrii · Jazz PharmsTo treat unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancerRevuforjCancer
revumenib · SyndaxTo treat relapsed or refractory acute leukemiaVyloyCancer
zolbetuximab-clzb · AstellasTo treat gastric or gastroesophageal junction adenocarcinomaItovebiCancer
inavolisib · Genentech Inc.To treat locally advanced or metastatic breast cancerLazcluzeCancer
lazertinib · Janssen BiotechTo treat non-small cell lung cancerVoranigoCancer
vorasidenibTo treat Grade 2 astrocytoma or oligodendrogliomaRyteloCancer
imetelstat · GeronTo treat low- to intermediate-1 risk myelodysplastic syndromesImdelltraCancer
tarlatamab-dlleTo treat extensive stage small cell lung cancerOjemdaCancer
tovorafenib · Day One BiopharmsTo treat relapsed or refractory pediatric low-grade gliomaAnktivaCancer
nogapendekin alfa inbakicept-pmln · Altor Bioscience, LLC, An Indirect Wholly-Owned SuTo treat bladder cancerTevimbraCancer
tislelizumab-jsgrTo treat unresectable or metastatic esophageal squamous cell carcinoma