FDA Approval Alert: The Need-to-Know
Epcoritamab in Relapsed/Refractory Follicular LymphomaNivolumab-Based Regimens for Esophageal Squamous Cell CarcinomaNivolumab/Ipilimumab in Unresectable/Metastatic Hepatocellular CarcinomaSelumetinib in Pediatric NF1-PNsAcalabrutinib Plus Bendamustine/Rituximab in Previously Untreated MCLIsatuximab/VRd in Transplant-Ineligible NDMMTXL007-CDx in Prostate CancerOsimertinib in Advanced EGFR-Mutated NSCLCEncorafenib/Cetuximab/mFOLFOX6 in Advanced BRAF V600E+ CRCLiso-Cel for Relapsed/Refractory LBCL in Second LinePembrolizumab/Chemotherapy in First-Line Gastric/GEJ AdenocarcinomaRibociclib/NSAI in HR+/HER2- Stage II-III Early Breast CancerAmivantamab/Lazertinib in Advanced EGFR+ NSCLCPerioperative Durvalumab in Resectable NSCLCElacestrant for ER+/HER2– Advanced Metastatic Breast CancerPonatinib/Chemotherapy in Ph+ Acute Lymphoblastic LeukemiaLarotrectinib in Adult and Pediatric NTRK+ Solid TumorsAdjuvant Durvalumab/Chemotherapy in Muscle-Invasive Bladder CancerTafasitamab Plus Lenalidomide/RItuximab in R/R Follicular LymphomaNilotinib Tablets in Ph+ CML in Chronic PhaseMirvetuximab Soravtansine Folate Receptor-α-Positive Platinum-Resistant Ovarian CancerLutetium Lu 177 in PSMA-Positive Metastatic Castration-Resistant Prostate CancerDarolutamide in Metastatic Castration-Sensitive Prostate CancerMirdametinib in Adult/Pediatric NF1-PNLiso-Cel for Relapsed/Refractory CLL/SLLTremelimumab Plus Durvalumab and Chemotherapy in Advanced Non–Small Cell Lung CancerDostarlimab Plus Chemotherapy in Advanced dMMR/MSI-H Endometrial CancerSubcutaneous Nivolumab in Solid TumorsVimseltinib in Tenosynovial Giant Cell TumorsZanidatamab in Metastatic HER2-Positive Biliary Tract CancerRetifanlimab/Chemotherapy in Recurrent/Metastatic Anal CancerCapivasertib Plus Fulvestrant in Advanced HR+, HER2– Breast CancerSunvozertinib in EGFR Exon 20+ NSCLCTisotumab Vedotin for Recurrent/Metastatic Cervical Cancer Zanubrutinib Tablets in Multiple Hematologic IndicationsMirvetuximab Soravtansine in FRα+ Ovarian CancerAlectinib for Early-Stage ALK+ NSCLCSacituzumab Govitecan-hziy in Pre-Treated HR+/HER2– Advanced Breast CancerNivolumab Plus Cisplatin/Gemcitabine for Unresectable Urothelial CarcinomaDostarlimab/Chemotherapy in Advanced or Recurrent Endometrial CancerPafolacianine for Ovarian Cancer Detection During SurgeryRepotrectinib in NTRK Gene Fusion-Positive Solid TumorsRemestemcel-L in Pediatric Steroid-Refractory Acute GVHDTrastuzumab Deruxtecan in HER2-Low/Ultralow Breast CancerBlinatumomab in CD19+ Ph– B-Cell Precursor Acute Lymphoblastic LeukemiaTaletrectinib in Locally Advanced or Metastatic ROS1+ NSCLC177Lu-PSMA-617 for Pretreated PSMA+ Metastatic Castration-Resistant Prostate CancerSIR-Sphere Y-90 in Hepatocellular CarcinomaAsciminib in Ph+ Chronic Myeloid Leukemia in Chronic PhaseFruquintinib for Previously Treated Metastatic Colorectal CancerGemcitabine Intravesical System in BCG-Unresponsive NMIBCDurvalumab/Chemotherapy in dMMR Advanced Endometrial CancerObecabtagene Autoleucel in B-Cell Acute Lymphoblastic LeukemiaTislelizumab in Metastatic Esophageal Squamous Cell CarcinomaCiltacabtagene Autoleucel for Relapsed/Refractory Multiple MyelomaZongertinib in HER2+ Metastatic or Unresectable Nonsquamous NSCLCAxicabtagene Ciloleucel for Relapsed/Refractory Large B-cell Lymphoma Following Chemoimmunotherapy Teclistamab-cqyv for Relapsed/Refractory Multiple MyelomaAdagrasib for KRAS G12C–Mutated NSCLCPerioperative Pembrolizumab Plus Radiation in Locally Advanced HNSCCAdjuvant Pembrolizumab for Resected NSCLCPembrolizumab for Advanced MSI-H/dMMR Endometrial CancerCabozantinib in Pancreatic/Extra-Pancreatic Neuroendocrine TumorsLuspatercept for Anemia Related to Low-Risk Myelodysplastic SyndromeTreosulfan/Fludarabine Injection for HSCT Conditioning in AML/MDSAfamitresgene Autoleucel in Unresectable Synovial SarcomaIntravesical Mitomycin Solution in Low-Grade Intermediate-Risk NMIBCMosunetuzumab for Relapsed/Refractory Follicular LymphomaOlaparib Plus Abiraterone and Prednisone/Prednisolone in BRCA-Mutated mCRPCAdagrasib/Cetuximab in KRAS G12C-Mutated Colorectal CancerZolbetuximab/Chemotherapy in Advanced CLDN18.2+ Gastric/GEJ AdenocarcinomaBelzutifan in Adult/Pediatric Pheochromocytoma and ParagangliomaPembrolizumab/Chemotherapy in Advanced/Recurrent Endometrial CarcinomaLisocabtagene Maraleucel in Relapsed/Refractory Follicular LymphomaAvutometinib/Defactinib in KRAS+ Low-Grade Serous Ovarian CancerSotorasib/Panitumumab in KRAS G12C-Mutated Colorectal CancerNivolumab/Ipilimumab in Adult/Pediatric MSI-H or dMMR CRCVorasidenib in Grade 2 IDH+ Astrocytoma/OligodendrogliomaCosibelimab in Cutaneous Squamous Cell CarcinomaZanubrutinib/Obinutuzumab for Relapsed/Refractory Follicular LymphomaTislelizumab/Chemotherapy in Unresectable or Metastatic PD-L1+ ESCCBrentuximab Vedotin Plus Lenalidomide/Rituximab in R/R LBCLAxatilimab in Pediatric/Adult Chronic GVHDInavolisib/Palbociclib/Fulvestrant in PIK3CA+ Advanced Breast CancerEnfortumab Vedotin Plus Pembrolizumab in Locally Advanced or Metastatic Urothelial CarcinomaTislelizumab/Chemotherapy in Gastric/GEJ AdenocarcinomaTucatinib Plus Trastuzumab for Advanced HER2+ Metastatic CRC Amivantamab/Chemotherapy in EGFR-Mutated NSCLCNogapendekin Alfa-inbakicept/BCG in BCG-unresponsive NMIBC Toripalimab for Recurrent/Metastatic Nasopharyngeal CarcinomaDenileukin Diftitox in Relapsed/Refractory Cutaneous T-Cell LymphomaPembrolizumab/Chemoradiation in Stage III/IVA Cervical CancerBetibeglogene Autotemcel for Transfusion-Dependent Beta-ThalassemiaLisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell LymphomaTremelimumab Plus Durvalumab for Unresectable Hepatocellular Carcinoma Nirogacestat in Desmoid TumorsDatopotamab Deruxtecan in Metastatic HR+/HER2– Breast CancerPenpulimab in Non-Keratinizing Nasopharyngeal CarcinomaLinvoseltamab in Relapsed/Refractory Multiple MyelomaTelisotuzumab Vedotin in c-MET+ NSCLC
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