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FDA New Molecular Entities [2011-November 2024] 第1頁
| Drug Name | Active Ingredient | Combo/single | ATC Index | AHFS Class | Date of Approval | Mechanism | Treatment | TFDA approval | |
| 1 | Pepaxto | melphalan flufenamide | Single | L01AA10 | 10:00 | 2021/3/10 | cytotoxic- alkylating | To treat relapsed or refractory multiple myeloma | |
| 2 | Inqovi | decitabine, cedazuridine | Combo | L01BC58 | 10:00 | 2020/7/31 | cytotoxic- antimetabolite | To treat adult patients with myelodysplastic syndromes | |
| 3 | Lonsurf | trifluridine, tipiracil | Combo | L01BC59 | 10:00 | 2015/10/6 | cytotoxic- antimetabolite | To treat patients with an advanced form of colorectal cancer who are no longer responding to other therapies | |
| 4 | Yondelis | trabectedin | Single | L01CX01 | 10:00 | 2015/11/4 | cytotoxic- alkylating | To treat specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). | Y |
| 5 | Scemblix | asciminib | Single | L01EA06 | 10:00 | 2021/10/29 | allosteric inhibitor of BCR-ABL1 protein | To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria | |
| 6 | Gilotrif | afatinib | Single | L01EB03 | 10:00 | 2013/9/30 | Target, EGFR kinase inhibitor | For patients with late stage (metastatic) non-small cell lung cancer (NSCLC) whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. | Y |
| 7 | Tagrisso | osimertinib | Single | L01EB04 | 10:00 | 2015/11/20 | Target, EGFR kinase inhibitor | To treat certain patients with non-small cell lung cancer | Y |
| 8 | Vizimpro | dacomitinib | Single | L01EB07 | 10:00 | 2018/10/1 | Target, EGFR/HER1, HER2, and HER4 kinase inhibitor- | To treat metastatic non-small-cell lung cancer | |
| 9 | Lazcluze | lazertinib | Single | L01EB09 | 10:00 | 2024/8/19 | Target, EGFR kinase inhibitor | To treat non-small cell lung cancer | |
| 10 | Tafinlar | dabrafenib | Single | L01EC02 | 10:00 | 2013/7/12 | Target, BRAF kinase inhibitor | To treat patients with melanoma whose tumors express the BRAF V600E gene mutation. | |
| 11 | Braftovi | encorafenib | Single | L01EC03 | 10:00 | 2018/7/20 | Target, BRAF kinase inhibitor | To treat unresectable or metastatic melanoma | |
| 12 | Zykadia | ceritinib | Single | L01ED02 | 10:00 | 2014/5/20 | Target, ALK kinase inhibitor | To treat patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC) | |
| 13 | Alecensa | alectinib | Single | L01ED03 | 10:00 | 2015/12/22 | Target, ALK and RET kinase inhibitor | To treat ALK-positive lung cancer | |
| 14 | Alunbrig | brigatinib | Single | L01ED04 | 10:00 | 2017/4/28 | Target, ALK kinase inhibitor | To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib | |
| 15 | Lorbrena | lorlatinib | Single | L01ED05 | 10:00 | 2018/11/16 | Target, ALK/ROS1 kinase inhibitor | To treat patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer | |
| 16 | Mekinist | trametinib | Single | L01EE01 | 10:00 | 2013/8/12 | Target, MEK1/2 kinase inhibitor | To treat patients whose tumors express the BRAF V600E or V600K gene mutations | |
| 17 | Cotellic | cobimetinib | Single | L01EE02 | 10:00 | 2015/11/16 | Target, MEK1/2 kinase inhibitor | To be used in combination with vemurafenib to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation) | |
| 18 | Mektovi | binimetinib | Single | L01EE03 | 10:00 | 2018/7/13 | Target, MEK1/2 kinase inhibitor | To treat unresectable or metastatic melanoma | |
| 19 | Koselugo | selumetinib | Single | L01EE04 | 10:00 | 2020/4/17 | Target, MEK1/2 kinase inhibitor | To treat neurofibromatosis type 1, a genetic disorder of the nervous system causing tumors to grow on nerves | |
| 20 | Ibrance | palbociclib | Single | L01EF01 | 10:00 | 2015/2/23 | Target, CDK4/6 inhibitor | To treat advanced (metastatic) breast cancer | |
| 21 | Kisqali | ribociclib | Single | L01EF02 | 10:00 | 2017/3/23 | Target, CDK4/6 inhibitor | To treat postmenopausal women with a type of advanced breast cancer | |
| 22 | Verzenio | abemaciclib | Single | L01EF03 | 10:00 | 2017/11/2 | Target, CDK4/6 inhibitor | To treat certain advanced or metastatic breast cancers | |
| 23 | Nerlynx | neratinib | Single | L01EH02 | 10:00 | 2017/8/1 | Target, EGFR/HER2/HER4 kinase inhibitor | To reduce the risk of breast cancer returning | |
| 24 | Tukysa | tucatinib | Single | L01EH03 | 10:00 | 2020/4/22 | Target, HER2 kinase inhibitor | To treat advanced unresectable or metastatic HER2-positive breast cancer | |
| 25 | Inrebic | fedratinib | Single | L01EJ02 | 10:00 | 2019/8/19 | Target, JAK2/FLT3 inhibitor | To treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis | |
| 26 | Vonjo | pacritinib | Single | L01EJ03 | 10:00 | 2022/2/28 | Target, multiple kinase inhibitor | To treat intermediate or high-risk primary or secondary myelofibrosis in adults with low platelets | |
| 27 | Ojjaara | momelotinib | Single | L01EJ04 | 10:00 | 2023/9/15 | Target, multiple kinase inhibitor | To treat intermediate or high-risk myelofibrosis in adults with anemia | |
| 28 | Fotivda | tivozanib | Single | L01EK03 | 10:00 | 2021/3/22 | Target, multiple kinase inhibitor | To treat renal cell carcinoma | |
| 29 | Fruzaqla | fruquintinib | Single | L01EK04 | 10:00 | 2023/11/8 | Target, VEGFR kinase inhibitor | To treat refractory, metastatic colorectal cancer | |
| 30 | Imbruvica | ibrutinib | Single | L01EL01 | 10:00 | 2013/11/22 | Target, BTK inhibitor | To treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer. | |
| 31 | Calquence | acalabrutinib | Single | L01EL02 | 10:00 | 2017/11/8 | Target, BTK inhibitor | To treat adults with mantle cell lymphoma | |
| 32 | Brukinsa | zanubrutinib | Single | L01EL03 | 10:00 | 2019/11/15 | Target, BTK inhibitor | To treat certain patients with mantle cell lymphoma, a form of blood cancer | |
| 33 | Jaypirca | pirtobrutinib | Single | L01EL05 | 10:00 | 2023/1/27 | Target, BTK inhibitor | To treat relapsed or refractory mantle cell lymphoma in adults who have had at least two lines of systemic therapy, including a BTK inhibitor | |
| 34 | Zydelig | idelalisib | Single | L01EM01 | 10:00 | 2014/8/1 | Target, PI3K inhibitor | To treat patients with trhee types of blood cancers | |
| 35 | Aliqopa | copanlisib | Single | L01EM02 | 10:00 | 2017/9/28 | Target, PI3K inhibitor | To treat adults with relapsed follicular lymphoma | |
| 36 | Piqray | alpelisib | Single | L01EM03 | 10:00 | 2019/6/21 | Target, PI3K inhibitor | To treat breast cancer | |
| 37 | Copiktra | duvelisib | Single | L01EM04 | 10:00 | 2018/9/27 | Target, PI3K inhibitor | To treat relapsed or refractory chronic lymphocytic leukemia, small lymphocytic lymphoma and follicular lymphoma | |
| 38 | Balversa | erdafitinib | Single | L01EN01 | 10:00 | 2019/5/3 | Target, FGFR kinase inhibitor | To treat adult patients with locally advanced or metastatic bladder cancer | |
| 39 | Pemazyre | pemigatinib | Single | L01EN02 | 10:00 | 2020/4/24 | Target, FGFR kinase inhibitor | To treat certain patients with cholangiocarcinoma, a rare form of cancer that forms in bile ducts | |
| 40 | Truseltiq | infigratinib | Single | L01EN03 | 10:00 | 2021/5/28 | Target, FGFR kinase inhibitor | To treat cholangiocarcinoma whose disease meets certain criteria | |
| 41 | Lytgobi | futibatinib | Single | L01EN04 | 10:00 | 2022/9/30 | Target, FGFR kinase inhibitor | To treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements | |
| 42 | Stivarga | regorafenib | Single | L01EX05 | 10:00 | 2012/10/22 | Target, multiple kinase inhibitor | To treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body (metastatic). | |
| 43 | Lenvima | lenvatinib | Single | L01EX08 | 10:00 | 2015/2/25 | Target, multiple kinase inhibitor | To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). | |
| 44 | Rydapt | midostaurin | Single | L01EX10 | 10:00 | 2017/5/1 | Target, multiple kinase inhibitor | To treat acute myeloid leukemia, advanced systemic mastocytosis | |
| 45 | Vanflyta | quizartinib | Single | L01EX11 | 10:00 | 2023/7/20 | Target, FLT3 kinase inhibitor | To use as part of a treatment regimen for newly diagnosed acute myeloid leukemia that meets certain criteria | |
| 46 | Vitrakvi | larotrectinib | Single | L01EX12 | 10:00 | 2018/11/28 | Target, NTRK inhibitor | To treat patients whose cancers have a specific genetic feature (biomarker) | |
| 47 | Xospata | gilteritinib | Single | L01EX13 | 10:00 | 2018/12/20 | Target, FLT3 kinase inhibitor | To treat patients who have relapsed or refractory acute myeloid leukemia (AML) | |
| 48 | Rozlytrek | entrectinib | Single | L01EX14 | 10:00 | 2019/8/16 | Target, NTRK, ROS1, and ALK kinase inhibitor | To treat adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive To treat adult and pediatric patients 12 years of age and older with solid tumors |
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| 49 | Turalio | pexidartinib | Single | L01EX15 | 10:00 | 2019/8/14 | Target, CSF1R, KIT, FLT3, ITD mutation kinase inhibitor | To treat adult patients with symptomatic tenosynovial giant cell tumor | |
| 50 | Tabrecta | capmatinib | Single | L01EX17 | 10:00 | 2020/5/15 | Target, MET kinase inhibitor | To treat patients with non small cell lung cancer | |
| 51 | Ayvakit | avapritinib | Single | L01EX18 | 10:00 | 2020/1/23 | Target, multiple kinase inhibitor | To treat adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) | |
| 52 | Qinlock | ripretinib | Single | L01EX19 | 10:00 | 2020/5/26 | Target, multiple kinase inhibitor | To treat advanced gastrointestinal-stromal tumors | |
| 53 | Tepmetko | tepotinib | Single | L01EX21 | 10:00 | 2021/2/11 | Target, MET kinase inhibitor | To treat non-small cell lung cancer | |
| 54 | Retevmo | selpercatinib | Single | L01EX22 | 10:00 | 2020/5/20 | Target, RET/VEGFR/FGFR kinase inhibitor | To treat lung and thyroid cancers | |
| 55 | Gavreto | pralsetinib | Single | L01EX23 | 10:00 | 2020/10/22 | Target, RET/multiple kinase inhibitor | To treat non-small lung cancer | |
| 56 | Ukoniq | umbralisib | Single | L01EX25 | 10:00 | 2021/2/12 | Target, multiple kinase inhibitor | To treat marginal zone lymphoma and follicular lymphoma | |
| 57 | Truqap | capivasertib | Single | L01EX27 | 10:00 | 2023/11/16 | Target, AKT/PI3K/PTEN kinase inhibitor | To treat breast cancer that meets certain disease criteria | |
| 58 | Augtyro | repotrectinib | Single | L01EX28* | 10:00 | 2023/11/15 | Target, ROS1/TRK kinase inhibitor | To treat ROS1-positive non-small cell lung cancer | |
| 59 | Gazyva | obinutuzumab | Single | L01FA03 | 10:00 | 2013/11/13 | Target, mab, CD20 | For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL). | |
| 60 | Besponsa | inotuzumab ozogamicin | Single | L01FB01 | 10:00 | 2017/8/29 | Target, ADC, CD22 | To treat adults with relapsed or refractory acute lymphoblastic leukemia | |
| 61 | Lumoxiti | moxetumomab pasudotox | Single | L01FB02 | 10:00 | 2018/9/24 | Target, Antibody Targeted Toxin | To treat hairy cell leukemia | |
| 62 | Darzalex | daratumumab | Single | L01FC01 | 10:00 | 2015/11/24 | Target, mab, CD38 | To treat patients with multiple myeloma who have received at least three prior treatments. | |
| 63 | Sarclisa | isatuximab | Single | L01FC02 | 10:00 | 2020/3/25 | Target, mab, CD38 | To treat multiple myloma | |
| 64 | Kadcyla | ado-trastuzumab emtansine | Single | L01FD03 | 10:00 | 2013/3/13 | Target, ADC, HER2 | For patients with HER2-positive, late-stage (metastatic) breast cancer. | |
| 65 | Enhertu | fam-trastuzumab deruxtecan | Single | L01FD04 | 10:00 | 2020/1/9 | Target, ADC, HER2 | To treat metastatic breast cancer | |
| 66 | Margenza | margetuximab | Single | L01FD06 | 10:00 | 2020/12/21 | Target, mab, HER2 | To treat HER2+ breast cancer | |
| 67 | Portrazza | necitumumab | Single | L01FE03 | 10:00 | 2015/12/8 | Target, mab, EGFR | To treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer | |
| 68 | Opdivo | nivolumab | Single | L01FF01 | 10:00 | 2015/1/21 | Immunotherapy, mab, PD-1 | To treat patients with unresectable (cannot be removed by surgery) or metastatic (advanced) melanoma who no longer respond to other drugs | |
| 69 | Keytruda | pembrolizumab | Single | L01FF02 | 10:00 | 2014/9/18 | Immunotherapy, mab, PD-1 | For treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. | |
| 70 | Imfinzi | durvalumab | Single | L01FF03 | 10:00 | 2017/5/22 | Immunotherapy, mab, PD-L1 | To treat patients with locally advanced or metastatic urothelial carcinoma | |
| 71 | Bavencio | avelumab | Single | L01FF04 | 10:00 | 2017/3/27 | Immunotherapy, mab, PD-L1 | To treat metastatic Merkel cell carcinoma | |
| 72 | Tecentriq | atezolizumab | Single | L01FF05 | 10:00 | 2016/5/27 | Immunotherapy, mab, PD-L1 | To treat urothelial carcinoma, the most common type of bladder cancer | |
| 73 | Libtayo | cemiplimab | Single | L01FF06 | 10:00 | 2018/10/2 | Immunotherapy, mab, PD-1 | To treat cutaneous squamous cell carcinoma (CSCC) | |
| 74 | Jemperli | dostarlimab | Single | L01FF07 | 10:00 | 2021/5/14 | Immunotherapy, mab, PD-1 | To treat endometrial cancer | |
| 75 | Tevimbra | tislelizumab | Single | L01FF09 | 10:00 | 2024/3/13 | Immunotherapy, mab, PD-1 | To treat unresectable or metastatic esophageal squamous cell carcinoma | |
| 76 | Zynyz | retifanlimab | Single | L01FF10 | 10:00 | 2023/3/22 | Immunotherapy, mab, PD-1 | To treat metastatic or recurrent locally advanced Merkel cell carcinoma | |
| 77 | Loqtorzi | toripalimab | Single | L01FF13 | 10:00 | 2023/10/27 | Immunotherapy, mab, PD-1 | To treat recurrent or metastatic nasopharyngeal carcinoma when used together with or following other therapies | |
| 78 | Cyramza | ramucirumab | Single | L01FG02 | 10:00 | 2014/5/8 | VEGF receptor 2 antagonist | To treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma | |
| 79 | Unituxin | dinutuximab | Single | L01FX06 | 10:00 | 2015/4/15 | binds GD2 on tumor cells to induce cell lysis | To treat pediatric patients with high-risk neuroblastoma | |
| 80 | Blincyto | blinatumomab | Single | L01FX07 | 10:00 | 2014/12/19 | bispecific mab, CD3 and CD19 | To treat patients with Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL) | |
| 81 | Empliciti | elotuzumab | Single | L01FX08 | 10:00 | 2015/12/11 | targets SLAMF7 and Fc receptors to activate natural killer cells | To treat people with multiple myeloma who have received one to three prior medications | |
| 82 | Poteligeo | mogamulizumab-kpkc | Single | L01FX09 | 10:00 | 2018/8/10 | CCR4-mediated signal transduction pathway inhibitor | To treat two rare types of non-Hodgkin lymphoma | |
| 83 | Lartruvo | olaratumab | Single | L01FX10 | 10:00 | 2016/12/14 | PDGFR-α antagonist | To treat adults with certain types of soft tissue sarcoma | |
| 84 | Monjuvi | tafasitamab-cxix | Single | L01FX12 | 10:00 | 2020/8/6 | mab, CD19 | To treat relapsed or refractory diffuse large B-cell lymphoma | |
| 85 | Padcev | enfortumab vedotin-ejfv | Single | L01FX13 | 10:00 | 2019/12/20 | antibody-drug conjugate directed against nectin-4 | To treat refractory bladder cancer | |
| 86 | Polivy | polatuzumab vedotin-piiq | Single | L01FX14 | 10:00 | 2019/7/3 | ADC, CD79b | To treat adult patients with relapsed or refractory diffuse large B-cell lymphoma | |
| 87 | Blenrep | belantamab mafodotin-blmf | Single | L01FX15 | 10:00 | 2020/8/7 | antibody-dependent cell-mediated cytotoxicity | To treat multiple myeloma | |
| 88 | Trodelvy | sacituzumab govitecan-hziy | Single | L01FX17 | 10:00 | 2020/5/6 | Trop-2-directed antibody and topoisomerase inhibitor conjugate drug | To treat adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease | |
| 89 | Rybrevant | amivantamab-vmjw | Single | L01FX18 | 10:00 | 2021/5/26 | bispecific mab, EGFR and MET | To treat a subset of non-small cell lung cancer | |
| 90 | Imjudo | tremelimumab | Single | L01FX20 | 10:00 | 2022/10/21 | CTLA-4 inhibitor | To treat unresectable hepatocellular carcinoma | |
| 91 | Danyelza | naxitamab-gqgk | Single | L01FX21 | 10:00 | 2020/12/3 | binds glycolipid GD2 to trigger cell death | To treat high-risk refractory or relapsed neuroblastoma | |
| 92 | Zynlonta | loncastuximab tesirine-lpyl | Single | L01FX22 | 10:00 | 2021/5/21 | binds C19, gets internalized into tumor cell, and damages lymphoma’s DNA | To treat certain types of relapsed or refractory large B-cell lymphoma | |
| 93 | Tivdak | tisotumab vedotin-tftv | Single | L01FX23 | 10:00 | 2021/9/20 | binds to tissue factor on surface of cancer cells | To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy | |
| 94 | Tecvayli | teclistamab-cqyv | Single | L01FX24 | 10:00 | 2022/10/25 | bispecific mab, BCMA and CD3 | To treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy | |
| 95 | Lunsumio | mosunetuzumab-axgb | Single | L01FX25 | 10:00 | 2022/12/22 | bispecific mab, CD20 and CD3 | To treat adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma | |
| 96 | Elahere | mirvetuximab soravtansine-gynx | Single | L01FX26 | 10:00 | 2022/11/14 | ADC | To treat patients with recurrent ovarian cancer that is resistant to platinum therapy | |
| 97 | Epkinly | epcoritamab-bysp | Single | L01FX27 | 10:00 | 2023/5/19 | bispecific mab, CD3 and CD20 | 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 | |
| 98 | Columvi | glofitamab-gxbm | Single | L01FX28 | 10:00 | 2023/6/15 | bispecific mab, CD3 and CD20 | 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 | |
| 99 | Talvey | talquetamab-tgvs | Single | L01FX29 | 10:00 | 2023/8/9 | bispecific mab, CD3 and GPRC5D | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies | |
| 100 | Vyloy | zolbetuximab-clzb | Single | L01FX31* | 10:00 | 2024/10/18 | mab, CLDN18.2 | To treat gastric or gastroesophageal junction adenocarcinoma | |
| 101 | Elrexfio | elranatamab-bcmm | Single | L01FX32* | 10:00 | 2023/8/14 | bispecific mab, BCMA and CD3 | To treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy | |
| 102 | Imdelltra | tarlatamab-dlle | Single | L01FX33* | 10:00 | 2024/5/16 | bispecific mab, DLL3 and CD3 | To treat extensive stage small cell lung cancer | |
| 103 | Opdualag | nivolumab, relatlimab-rmbw | Combo | L01FY02 | 10:00 | 2022/3/18 | LAG-3 receptor and PD-1 inhibitor | To treat unresectable or metastatic melanoma | |
| 104 | Ninlaro | ixazomib | Single | L01XG03 | 10:00 | 2015/11/30 | reversible proteasome inhibitor that binds beta 5 subunit of 20S | To treat people with multiple myeloma who have received at least one prior therapy | |
| 105 | Farydak | panobinostat | Single | L01XH03 | 10:00 | 2015/3/6 | histone deacetylase inhibitor | To treat patients with multiple myeloma | |
| 106 | Beleodaq | belinostat | Single | L01XH04 | 10:00 | 2014/7/23 | HDAC inhibitor | To treat patients with peripheral T-cell lymphoma (PTCL) | |
| 107 | Odomzo | sonidegib | Single | L01XJ02 | 10:00 | 2015/8/18 | hedgehog pathway inhibitor | To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. | |
| 108 | Daurismo | glasdegib | Single | L01XJ03 | 10:00 | 2018/11/28 | hedgehog pathway inhibitor | To treat newly-diagnosed acute myeloid leukemia (AML) in adult patients | |
| 109 | Lynparza | olaparib | Single | L01XK01 | 10:00 | 2014/12/19 | PARP inhibitor | To treat advanced ovarian cancer | |
| 110 | Zejula | niraparib | Single | L01XK02 | 10:00 | 2017/3/28 | inhibits repair of damaged DNA, induces cell death | For the maintenance treatment for recurrent epithelial ovarian, fallopian tube or primary peritoneal cancers | |
| 111 | Rubraca | rucaparib | Single | L01XK03 | 10:00 | 2017/1/19 | PARP inhibitor | To treat women with a certain type of ovarian cancer | |
| 112 | Talzenna | talazoparib | Single | L01XK04 | 10:00 | 2018/11/2 | PARP1 and PART2 inhibitor | To treat locally advanced or metastatic breast cancer patients with a germline BRCA mutation. | |
| 113 | Rezlidhia | olutasidenib | Single | L01XM03* | 10:00 | 2022/12/1 | IDHI inhibitor | To treat adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation | |
| 114 | Voranigo | vorasidenib | Single | L01XM04* | 10:00 | 2024/8/6 | IDH1 and IDH2 inhibitor | To treat Grade 2 astrocytoma or oligodendroglioma | |
| 115 | Rylaze | asparaginase erwinia chrysanthemi (recombinant)-rywn | Single | L01XX02 | 10:00 | 2021/6/30 | catalyzing conversion of L-asparagine into aspartic acid and ammonia | 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 | |
| 116 | Venclexta | venetoclax | Single | L01XX52 | 10:00 | 2016/5/18 | binds BCL-2 and displaces BIM and other proteins that activate apoptosis | For chronic lymphocytic leukemia in patients with a specific chromosomal abnormality | |
| 117 | Idhifa | enasidenib | Single | L01XX59 | 10:00 | 2017/8/17 | IDH2 inhibitor | To treat relapsed or refractory acute myeloid leukemia | |
| 118 | Tibsovo | ivosidenib | Single | L01XX62 | 10:00 | 2018/7/23 | isocitrate dehydrogenase-1 inhibitor | To treat patients with relapsed or refractory acute myeloid leukemia | |
| 119 | Xpovio | selinexor | Single | L01XX66 | 10:00 | 2019/7/25 | XPO1 blocker | To treat adult patients with relapsed or refractory multiple myeloma (RRMM) | |
| 120 | Elzonris | tagraxofusp-erzs | Single | L01XX67 | 10:00 | 2019/1/2 | delivers cytotoxic diphtheria toxin to the cells to cause cell death | To treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) | |
| 121 | Zepzelca | lurbinectedin | Single | L01XX69 | 10:00 | 2020/7/2 | selective inhibitor of oncogenic transcription | To treat metastatic small cell lung cancer | |
| 122 | Tazverik | tazemetostat | Single | L01XX72 | 10:00 | 2020/2/21 | EZH2 inhibitor | To treat epithelioid sarcoma | |
| 123 | Lumakras | sotorasib | Single | L01XX73 | 10:00 | 2021/5/28 | KRAS G12C inhibitor | To treat types of non-small cell lung cancer | |
| 124 | Welireg | belzutifan | Single | L01XX74 | 10:00 | 2021/8/13 | HIF-2 alpha inhibitor | To treat von Hippel-Lindau disease under certain conditions | |
| 125 | Kimmtrak | tebentafusp-tebn | Single | L01XX75 | 10:00 | 2022/1/25 | bispecific mab, HLA-A and CD3 | To treat unresectable or metastatic uveal melanoma | |
| 126 | Krazati | adagrasib | Single | L01XX77 | 10:00 | 2022/12/12 | KRAS G12C inhibitor | 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 | |
| 127 | Rytelo | imetelstat | Single | L01XX80 | 10:00 | 2024/6/6 | telomerase inhibitor | To treat low- to intermediate-1 risk myelodysplastic syndromes | |
| 128 | Ogsiveo | nirogacestat | Single | L01XX81* | 10:00 | 2023/11/27 | gamma secretase inhibitor | To treat adults with progressing desmoid tumors who require systemic treatment | |
| 129 | Orserdu | elacestrant | Single | L02BA04 | 10:00 | 2023/1/27 | estrogen antagonist | 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 | |
| 130 | Erleada | apalutamide | Single | L02BB05 | 10:00 | 2018/3/20 | AR nuclear translocation inhibitor | To treat a certain type of prostate cancer using novel clinical trial endpoint | |
| 131 | Nubeqa | darolutamide | Single | L02BB06 | 10:00 | 2019/8/14 | androgen receptor inhibitor | To treat adult patients with non-metastatic castration resistant prostate cancer | |
| 132 | Besremi | ropeginterferon alfa-2b-njft | Single | L03AB15 | 10:00 | 2021/11/12 | binds to IFNAR to activate downstream JAK1, TYK2, and STAT proteins | To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells | |
| 133 | Sylvant | siltuximab | Single | L04AC11 | 10:00 | 2014/5/8 | binds human IL-6 to prevent its binding to IL-6 soluble and membrane-bound receptors | To treat patients with multicentric Castleman’s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph nodes) | |
| 134 | Pomalyst | pomalidomide | Single | L04AX06 | 10:00 | 2013/2/26 | To treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. | ||
| 135 | Lutathera | lutetium Lu 177 dotatate | Single | V10XX04 | 10:00 | 2018/2/12 | delivers beta minus radiation to SSTR-expressing cells | To treat a type of cancer that affects the pancreas or gastrointestinal tract called gastroenteropancreatic neuroendocrine tumors (GEP-NETs). | |
| 136 | Zytiga | abiraterone acetate | Single | 10:00 | 2011/4/28 | androgen biosynthesis inhibitor | In combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy). | ||
| 137 | Yervoy | ipilimumab | Single | 10:00 | 2011/3/25 | binds CTLA-4, a negative regulator of T-cell activation | To treat patients with late-stage (metastatic) melanoma, the most dangerous type of skin cancer. | ||
| 138 | Bizengri | zenocutuzumab-zbco | Single | 10:00 | 2024/12/4 | bispecific mab, HER2 and HER3 | To treat non-small cell lung cancer and pancreatic adenocarcinoma | ||
| 139 | Asparlas | calaspargase pegol-mknl | Single | 10:00 | 2018/12/21 | catalyzes conversion of L-asparagine into aspartic acid and ammonia | To treat acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years | ||
| 140 | Erwinaze | asparaginase Erwinia chrysanthemi | Single | 10:00 | 2012/1/17 | hydrolyzes L-asparagine to L-aspartic acid and ammonia | To treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL. | ||
| 141 | Anktiva | nogapendekin alfa, inbakicept-pmln | Combo | 10:00 | 2024/4/22 | IL-15 agonist | To treat bladder cancer | ||
| 142 | Revuforj | revumenib | Single | 10:00 | 2024/11/15 | menin inhibitor | To treat relapsed or refractory acute leukemia | ||
| 143 | Itovebi | inavolisib | Single | 10:00 | 2024/10/10 | PI3K inhibitor | To treat locally advanced or metastatic breast cancer | ||
| 144 | Ojemda | tovorafenib | Single | 10:00 | 2024/4/23 | RAF kinase inhibitor | To treat relapsed or refractory pediatric low-grade glioma | ||
| 145 | Perjeta | pertuzumab | Single | 10:00 | 2012/6/28 | To treat patients with HER2-positive late-stage (metastatic) breast cancer. | |||
| 146 | Anoro Ellipta | umeclidinium, vilanterol inhalation powder | Combo | R03AL03 | 12:08 | 2014/1/31 | M3 antagonist | For the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). | |
| 147 | Yupelri | revefenacin | Single | R03BB08 | 12:08 | 2018/11/20 | M3 receptor inhibitor | To treat patients with chronic obstructive pulmonary disease (COPD) | |
| 148 | Northera | droxidopa | Single | C01CA27 | 12:12 | 2014/3/19 | inducing vasoconstriction to increase blood pressure | To treat neurogenic orthostatic hypotension (NOH) | |
| 149 | Lucemyra | lofexidine hydrochloride | Single | N07BC04 | 12:12 | 2018/5/18 | central alpha-2 adrenergic agonist | For the non-opioid treatment for management of opioid withdrawal symptoms in adults | |
| 150 | Striverdi | olodaterol | Single | R03AC19 | 12:12 | 2014/8/6 | beta2-adrenergic receptor agonist | To treat chronic obstructive pulmonary disease | |
| 151 | Letybo | letibotulinumtoxinA-wlbg | Single | M03AX01 | 12:20 | 2024/2/29 | botulinum toxin A | To temporarily improve the appearance of moderate-to-severe glabellar lines | |
| 152 | Accrufer | ferric maltol | Single | B03AB10 | 20:04 | 2019/8/2 | delivers iron for uptake across intestinal wall | To treat iron deficiency anemia in adults | |
| 153 | Kengreal | cangrelor | Single | B01AC25 | 20:12 | 2015/7/7 | P2Y12 platelet receptor inhibitor | To prevent the formation of harmful blood clots in the coronary arteries for adult patients undergoing percutaneous coronary intervention | |
| 154 | Zontivity | vorapaxar | Single | B01AC26 | 20:12 | 2014/5/23 | PAR-1 antagonist | To reduce the risk of heart attacks and stroke in high-risk patients | |
| 155 | Savaysa | edoxaban | Single | B01AF03 | 20:12 | 2015/1/23 | FXa inhibitor | To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem | |
| 156 | Bevyxxa | betrixaban | Single | B01AF04 | 20:12 | 2017/7/17 | FXa inhibitor | For the prophylaxis of venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness | |
| 157 | Defitelio | defibrotide sodium | Single | B01AX01 | 20:12 | 2016/4/29 | enhances plasmin activity to hydrolyze fibrin clots | To treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after they receive a stem cell transplant from blood or bone marrow called hematopoietic stem cell transplantation | |
| 158 | Cablivi | caplacizumab-yhdp | Single | B01AX07 | 20:12 | 2019/3/19 | microthrombi formation inhibitor that binds A1 domain of vWF | To treat adult patients with acquired thrombotic thrombocytopenic purpura (aTTP) | |
| 159 | Mulpleta | lusutrombopag | Single | B02BX07 | 20:16 | 2018/8/10 | TPO receptor agonist | To treat thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure | |
| 160 | Doptelet | avatrombopag | Single | B02BX08 | 20:16 | 2018/5/31 | TPO receptor agonist | To treat low blood platelet count (thrombocytopenia) in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure | |
| 161 | Reblozyl | luspatercept–aamt | Single | B03XA06 | 20:16 | 2019/11/14 | binds TGF-beta ligands to diminish Smad2/3 signaling | For the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions | |
| 162 | Jesduvroq | daprodustat | Single | B03XA07 | 20:16 | 2023/2/1 | HIF-PH inhibitor | To treat anemia caused by chronic kidney disease for adults on dialysis for at least four months | |
| 163 | Vafseo | vadadustat | Single | B03XA08 | 20:16 | 2024/3/27 | HIF-PH inhibitor | To treat anemia due to chronic kidney disease | |
| 164 | Ryzneuta | efbemalenograstim alfa-vuxw | Single | L03AA18 | 20:16 | 2023/11/16 | colony-stimulating factor | To treat neutropenia | |
| 165 | Rolvedon | eflapegrastim | Single | L03AA19 | 20:16 | 2022/9/9 | granulocyte colony-stimulating factor | 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 | |
| 166 | Aphexda | motixafortide | Single | L03AX23* | 20:16 | 2023/9/8 | CXCR4 inhibitor | To use with filgrastim (G-CSF) to mobilize hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with multiple myeloma | |
| 167 | Xolremdi | mavorixafor | Single | L03AX24* | 20:16 | 2024/4/26 | CXCR4 antagonist | To treat WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis) | |
| 168 | Hemlibra | emicizumab | Single | B02BX06 | 20:28 | 2017/12/11 | bispecific mab, factor X and factor IX | To prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. | |
| 169 | Hympavzi | marstacimab-hncq | Single | B02BX11* | 20:28 | 2024/10/11 | mab, TFPI Kunitz domain 2 | To prevent or reduce bleeding episodes related to hemophilia A or B | |
| 170 | Praxbind | idarucizumab | Single | V03AB37 | 20:28 | 2015/10/23 | binds dabigatran for the reversal of anticoagulant effects of dabigatran | For use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects. | |
| 171 | Tavalisse | fostamatinib | Single | B02BX09 | 20:92 | 2018/4/19 | SYK signaling inhibitor | To treat thrombocytopenia in adult patients with persistent or chronic immune thrombocytopenia (ITP) | |
| 172 | Adakveo | crizanlizumab-tmca | Single | B06AX01 | 20:92 | 2019/11/21 | inhibits P-selectin-mediated adhesive interactions | To treat patients with painful complication |