Https://www.neoplasm.org/wiki/Main Page/Update
Updates
| Approval date | Medication (Brand) | Company | Indication | Regulatory type | Trial(s) cited on FDA approval page |
|---|---|---|---|---|---|
| 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectibix) | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | Traditional approval | CodeBreaK 300 |
| 2025-01-16 | Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) | AstraZeneca | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT | Traditional approval | ELEVATE-TN |
| 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy | Accelerated approval | TROPION-Breast01 |
| 2025-01-21 | Treosulfan + Fludarabine (Grafapex) | medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | Traditional approval | MC-FludT.14/L Trial II |
| 2025-01-27 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | HR-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer | Traditional approval | DESTINY-Breast06 |
| 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks Therapeutics | Adult and pediatric patients ≥2 years with NF1-associated symptomatic plexiform neurofibromas | Traditional approval | ReNeu |
| 2025-02-11 | Brentuximab vedotin + Lenalidomide + Rituximab | Seagen (Pfizer) | Relapsed or refractory large B-cell lymphoma in patients ineligible for autologous HSCT or CAR-T therapy | Traditional approval | ECHELON-3 |
| 2025-02-14 | Vimseltinib (Romvimza) | Deciphera Pharmaceuticals | Tenosynovial giant cell tumor where surgical resection would cause severe morbidity | Traditional approval | MOTION |
| 2025-03-19 | Pembrolizumab + Trastuzumab + Chemotherapy | Merck | First-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma (PD-L1 CPS ≥1) | Traditional approval | KEYNOTE-811 |
| 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | Previously treated, unresectable or metastatic pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors | Traditional approval | CABINET |
| 2025-03-28 | Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) | Novartis | PSMA-positive metastatic castration-resistant prostate cancer | Traditional approval | PSMAfore |
| 2025-04-08 | Nivolumab + Ipilimumab | Bristol Myers Squibb | Unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer | Traditional approval | CheckMate-8HW |
| 2025-04-11 | Nivolumab + Ipilimumab | Bristol Myers Squibb | First-line treatment of unresectable or metastatic hepatocellular carcinoma | Traditional approval | CheckMate-9DW |
| 2025-04-23 | Penpulimab-kcqx | Akeso Biopharma | First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma | Traditional approval | AK105-304; AK105-202 |
| 2025-05-08 | Avutometinib + Defactinib | Verastem | KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy | Accelerated approval | RAMP-201 |
| 2025-05-14 | Belzutifan (Welireg) | Merck | Locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma | Traditional approval | LITESPARK-015 |
| 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-MET–overexpressing non-small cell lung cancer after prior systemic therapy | Accelerated approval | LUMINOSITY |
| 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Squamous cell carcinoma of the anal canal (first-line with chemotherapy or as monotherapy after platinum) | Traditional approval | POD1UM-303; POD1UM-202 |
| 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1-positive non-small cell lung cancer | Traditional approval | TRUST-I; TRUST-II |
| 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy | Accelerated approval | TROPION-Lung01; TROPION-Lung05 |
| 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal Pharma | EGFR exon 20 insertion NSCLC after platinum therapy | Accelerated approval | WU-KONG1 |
| 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed/refractory multiple myeloma (≥4 prior lines) | Accelerated approval | LINKER-MM1 |
| 2025-08-06 | Dordaviprone (Modeyso) | Jazz Pharmaceuticals | H3 K27M–mutant diffuse midline glioma | Accelerated approval | ACTION |
| 2025-08-08 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutated NSCLC after prior therapy | Accelerated approval | BEAMION-LUNG-1 |
| 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC with CIS | Traditional approval | SUNRISE-1 |
| 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+/HER2− metastatic breast cancer | Traditional approval | EMBER-3 |
| 2025-10-24 | Revumenib (Revuforj) | Syndax Pharmaceuticals | Relapsed/refractory NPM1-mutated AML | Accelerated approval | AUGMENT-101 |
| 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | Relapsed/refractory NPM1-mutated AML | Accelerated approval | KOMET-001 |
| 2025-11-18 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed/refractory follicular lymphoma | Traditional approval | EPCORE-NHL-1 |
| 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed/refractory marginal zone lymphoma | Traditional approval | TRANSCEND-NHL-001 |
Recent changes
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8 June 2026
| N 17:29 | Now That You've Purchased Top Fridge ... Now What? diffhist +6,506 Best-fridge-freezer7817 talk contribs (Created page with "Top Fridge Models for 2023: A Comprehensive Guide<br>When it pertains to kitchen home appliances, the fridge is arguably the most essential. It not only keeps our food fresh and safe to consume however also improves our cooking and dining experiences. With various designs available on the market, selecting the ideal fridge can be a daunting job. This blog post aims to assist readers through the leading [http://120.48.141.82:3000/fridges-freezers4127 fridge freezer to buy...") | ||||
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| N 17:24 | User:DanShell485534 diffhist +454 DanShell485534 talk contribs (Created page with "My name's Dan Shell but everybody calls me Dan. I'm from Great Britain. I'm studying at the high school (2nd year) and I play the Viola for 3 years. Usually I choose songs from the famous films ;). <br>I have two sister. I like American football, watching TV (Modern Family) and Conlanging.<br><br>Stop by my page; [https://prifactorengineers.com/common-mistakes-to-avoid-when-using-a-money-transfer-service-2/ Top international money transfer companies]") | ||||
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FDA approvals
| Approval date | Medication (Brand) | Company | Indication | Regulatory type | Trial(s) cited on FDA approval page |
|---|---|---|---|---|---|
| 2025-01-16 | Sotorasib + Panitumumab (Lumakras + Vectibix) | Amgen | KRAS G12C–mutated metastatic colorectal cancer after prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy | Traditional approval | CodeBreaK 300 |
| 2025-01-16 | Acalabrutinib + Bendamustine + Rituximab (Calquence-based regimen) | AstraZeneca | Previously untreated mantle cell lymphoma in adults who are not eligible for autologous HSCT | Traditional approval | ELEVATE-TN |
| 2025-01-17 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | HR-positive, HER2-negative unresectable or metastatic breast cancer after endocrine therapy and chemotherapy | Accelerated approval | TROPION-Breast01 |
| 2025-01-21 | Treosulfan + Fludarabine (Grafapex) | medac GmbH | Conditioning regimen for allogeneic hematopoietic stem cell transplantation in AML or MDS | Traditional approval | MC-FludT.14/L Trial II |
| 2025-01-27 | Fam-trastuzumab deruxtecan-nxki (Enhertu) | Daiichi Sankyo | HR-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer | Traditional approval | DESTINY-Breast06 |
| 2025-02-11 | Mirdametinib (Gomekli) | SpringWorks Therapeutics | Adult and pediatric patients ≥2 years with NF1-associated symptomatic plexiform neurofibromas | Traditional approval | ReNeu |
| 2025-02-11 | Brentuximab vedotin + Lenalidomide + Rituximab | Seagen (Pfizer) | Relapsed or refractory large B-cell lymphoma in patients ineligible for autologous HSCT or CAR-T therapy | Traditional approval | ECHELON-3 |
| 2025-02-14 | Vimseltinib (Romvimza) | Deciphera Pharmaceuticals | Tenosynovial giant cell tumor where surgical resection would cause severe morbidity | Traditional approval | MOTION |
| 2025-03-19 | Pembrolizumab + Trastuzumab + Chemotherapy | Merck | First-line treatment of HER2-positive gastric or gastroesophageal junction adenocarcinoma (PD-L1 CPS ≥1) | Traditional approval | KEYNOTE-811 |
| 2025-03-26 | Cabozantinib (Cabometyx) | Exelixis | Previously treated, unresectable or metastatic pancreatic neuroendocrine tumors and extra-pancreatic neuroendocrine tumors | Traditional approval | CABINET |
| 2025-03-28 | Lutetium Lu-177 vipivotide tetraxetan (Pluvicto) | Novartis | PSMA-positive metastatic castration-resistant prostate cancer | Traditional approval | PSMAfore |
| 2025-04-08 | Nivolumab + Ipilimumab | Bristol Myers Squibb | Unresectable or metastatic microsatellite instability–high or mismatch repair–deficient colorectal cancer | Traditional approval | CheckMate-8HW |
| 2025-04-11 | Nivolumab + Ipilimumab | Bristol Myers Squibb | First-line treatment of unresectable or metastatic hepatocellular carcinoma | Traditional approval | CheckMate-9DW |
| 2025-04-23 | Penpulimab-kcqx | Akeso Biopharma | First-line treatment of recurrent or metastatic non-keratinizing nasopharyngeal carcinoma | Traditional approval | AK105-304; AK105-202 |
| 2025-05-08 | Avutometinib + Defactinib | Verastem | KRAS-mutated recurrent low-grade serous ovarian cancer after prior systemic therapy | Accelerated approval | RAMP-201 |
| 2025-05-14 | Belzutifan (Welireg) | Merck | Locally advanced, unresectable, or metastatic pheochromocytoma or paraganglioma | Traditional approval | LITESPARK-015 |
| 2025-05-14 | Telisotuzumab vedotin-tllv (Emrelis) | AbbVie | c-MET–overexpressing non-small cell lung cancer after prior systemic therapy | Accelerated approval | LUMINOSITY |
| 2025-05-15 | Retifanlimab-dlwr (Zynyz) | Incyte | Squamous cell carcinoma of the anal canal (first-line with chemotherapy or as monotherapy after platinum) | Traditional approval | POD1UM-303; POD1UM-202 |
| 2025-06-11 | Taletrectinib (Ibtrozi) | Nuvation Bio | Locally advanced or metastatic ROS1-positive non-small cell lung cancer | Traditional approval | TRUST-I; TRUST-II |
| 2025-06-23 | Datopotamab deruxtecan-dlnk (Datroway) | Daiichi Sankyo | EGFR-mutated locally advanced or metastatic non-small cell lung cancer after EGFR-directed therapy and platinum chemotherapy | Accelerated approval | TROPION-Lung01; TROPION-Lung05 |
| 2025-07-02 | Sunvozertinib (Zegfrovy) | Dizal Pharma | EGFR exon 20 insertion NSCLC after platinum therapy | Accelerated approval | WU-KONG1 |
| 2025-07-02 | Linvoseltamab-gcpt (Lynozyfic) | Regeneron | Relapsed/refractory multiple myeloma (≥4 prior lines) | Accelerated approval | LINKER-MM1 |
| 2025-08-06 | Dordaviprone (Modeyso) | Jazz Pharmaceuticals | H3 K27M–mutant diffuse midline glioma | Accelerated approval | ACTION |
| 2025-08-08 | Zongertinib (Hernexeos) | Boehringer Ingelheim | HER2-mutated NSCLC after prior therapy | Accelerated approval | BEAMION-LUNG-1 |
| 2025-09-09 | Gemcitabine intravesical system (Inlexzo) | Janssen | BCG-unresponsive NMIBC with CIS | Traditional approval | SUNRISE-1 |
| 2025-09-25 | Imlunestrant (Inluriyo) | Eli Lilly | ESR1-mutated ER+/HER2− metastatic breast cancer | Traditional approval | EMBER-3 |
| 2025-10-24 | Revumenib (Revuforj) | Syndax Pharmaceuticals | Relapsed/refractory NPM1-mutated AML | Accelerated approval | AUGMENT-101 |
| 2025-11-13 | Ziftomenib (Komzifti) | Kura Oncology | Relapsed/refractory NPM1-mutated AML | Accelerated approval | KOMET-001 |
| 2025-11-18 | Epcoritamab-bysp (Epkinly) | Genmab | Relapsed/refractory follicular lymphoma | Traditional approval | EPCORE-NHL-1 |
| 2025-12-04 | Lisocabtagene maraleucel (Breyanzi) | Bristol Myers Squibb | Relapsed/refractory marginal zone lymphoma | Traditional approval | TRANSCEND-NHL-001 |