APO|APE Newshttps://www.apoapenews.com/Independent media covering cancer care, diagnostic pathology, immuno-oncology, ADCs, digital pathology, and precision medicine. Read by oncologists, pathologists, and the biopharma community worldwide.en-us International LGLL Consortium Publishes Consensus Criteria for Diagnosis, Treatment Initiation and Response Assessment in T-LGL Leukemiahttps://www.apoapenews.com/articles/t-lgl-leukemia-international-consensus-criteria-blood/https://www.apoapenews.com/articles/t-lgl-leukemia-international-consensus-criteria-blood/Wed, 26 Aug 2026 12:00:00 +0000HematologyA 23-author International LGLL Consortium report in Blood sets uniform diagnostic, treatment-initiation and response criteria for T-LGL leukemia. Johnson & Johnson Turned Rybrevant's Survival Win Into a Once-a-Month Injection, With More Planned for Amivantamabhttps://www.apoapenews.com/articles/jnj-rybrevant-lazcluze-egfr-lung-cancer-amivantamab-2026/https://www.apoapenews.com/articles/jnj-rybrevant-lazcluze-egfr-lung-cancer-amivantamab-2026/Wed, 26 Aug 2026 12:00:00 +0000OncologyHow Johnson & Johnson built on MARIPOSA: subcutaneous Rybrevant Faspro, monthly dosing, 61% sales growth and amivantamab's move into head and neck cancer. Summit and Akeso Land HARMONi in The Lancet Oncology as Ivonescimab Beats Durvalumab on Survival in a China Biliary Tract Cancer Trialhttps://www.apoapenews.com/articles/ivonescimab-harmoni-lancet-oncology-gi1-biliary-os/https://www.apoapenews.com/articles/ivonescimab-harmoni-lancet-oncology-gi1-biliary-os/Wed, 26 Aug 2026 12:00:00 +0000Immuno-OncologyHARMONi ivonescimab data reach The Lancet Oncology (PFS HR 0.52, OS HR 0.79) as Akeso says HARMONi-GI1 beat durvalumab on survival in biliary cancer. AstraZeneca Rebuilds Breast Cancer Treatment Around Enhertu, Datroway and a Blood Testhttps://www.apoapenews.com/articles/astrazeneca-breast-cancer-enhertu-datroway-camizestrant-fda-2026/https://www.apoapenews.com/articles/astrazeneca-breast-cancer-enhertu-datroway-camizestrant-fda-2026/Wed, 26 Aug 2026 12:00:00 +0000OncologyEnhertu in early HER2-positive disease, Datroway in first-line TNBC and a stalled camizestrant FDA review define AstraZeneca's 2026 breast cancer year. DNA Methylation Epitypes Sort 1,262 De Novo AML Patients and Catch Mutation Mimics That Genetic Testing Misseshttps://www.apoapenews.com/articles/aml-dna-methylation-epitypes-blood-prognosis-beyond-genetics/https://www.apoapenews.com/articles/aml-dna-methylation-epitypes-blood-prognosis-beyond-genetics/Wed, 26 Aug 2026 12:00:00 +0000HematologyA Blood paper from Ohio State sorts 1,262 de novo AML patients into 13 methylation epitypes that sharpen prediction of remission, relapse and survival. McKesson Signs Agreement to Acquire Precision Medicine Group for Approximately $2.25 Billionhttps://www.apoapenews.com/articles/mckesson-acquire-precision-medicine-group-2-25-billion/https://www.apoapenews.com/articles/mckesson-acquire-precision-medicine-group-2-25-billion/Tue, 25 Aug 2026 12:00:00 +0000Business & RegulatoryMcKesson will pay about $2.25 billion for Precision Medicine Group, a CRO and commercialization firm, and fold it into its oncology segment. FDA Approves Jazz's Bispecific HER2 Antibody Ziihera, With and Without BeOne's Tevimbra, for First-Line HER2-Positive Gastroesophageal Adenocarcinomahttps://www.apoapenews.com/articles/fda-approves-ziihera-tevimbra-first-line-her2-gea/https://www.apoapenews.com/articles/fda-approves-ziihera-tevimbra-first-line-her2-gea/Tue, 25 Aug 2026 12:00:00 +0000OncologyFDA approves Ziihera with and without Tevimbra plus chemotherapy in first-line HER2-positive gastroesophageal adenocarcinoma, with two Roche assays as CDx. Ataraxis AI Laboratory Receives CAP Accreditation and a California Clinical Laboratory License, Opening Ataraxis Breast to the Statehttps://www.apoapenews.com/articles/ataraxis-ai-lab-cap-accreditation-california-license/https://www.apoapenews.com/articles/ataraxis-ai-lab-cap-accreditation-california-license/Tue, 25 Aug 2026 12:00:00 +0000Digital Pathology & AIAtaraxis AI says its lab is now CAP-accredited and licensed in California, opening its H&E-based Ataraxis Breast AI tests to clinicians in the state. Allegheny Health Network and The START Center for Cancer Research Will Put an Early-Phase Trial Site Inside Allegheny General Hospitalhttps://www.apoapenews.com/articles/ahn-start-center-early-phase-cancer-trials-pittsburgh/https://www.apoapenews.com/articles/ahn-start-center-early-phase-cancer-trials-pittsburgh/Tue, 25 Aug 2026 12:00:00 +0000OncologyAllegheny Health Network and START will embed an early-phase oncology trial site in the AHN Cancer Center at Allegheny General Hospital in Pittsburgh. TwinStrand and the University of Washington Win a $245.2 Million Final Judgment Against Guardant Health, Which Says It Will Appealhttps://www.apoapenews.com/articles/twinstrand-guardant-duplex-sequencing-final-judgment-appeal/https://www.apoapenews.com/articles/twinstrand-guardant-duplex-sequencing-final-judgment-appeal/Mon, 24 Aug 2026 12:00:00 +0000Business & RegulatoryA Delaware court entered final judgment for TwinStrand and UW on two duplex sequencing patents and ordered a 6% Guardant royalty. Guardant will appeal. Pathology Foundation Models Plus Semi-Supervised Curation Detect Perineural Invasion in Colon, Prostate and Pancreatic H&E Slideshttps://www.apoapenews.com/articles/perineural-invasion-ai-virchow2-uni-semi-supervised-limerick/https://www.apoapenews.com/articles/perineural-invasion-ai-virchow2-uni-semi-supervised-limerick/Mon, 24 Aug 2026 12:00:00 +0000Digital Pathology & AIUniversity of Limerick study in Bioinformatics: Virchow-2 and UNI beat ImageNet CNNs at perineural invasion detection in colon, prostate and pancreas WSIs. Pattern Computer and MCW Report Early Results for a Three-Second Saliva Cancer Screen, With 91% Specificity and 44% Sensitivityhttps://www.apoapenews.com/articles/pattern-computer-mcw-saliva-hyperspectral-cancer-screening/https://www.apoapenews.com/articles/pattern-computer-mcw-saliva-hyperspectral-cancer-screening/Mon, 24 Aug 2026 12:00:00 +0000Molecular DiagnosticsA 251-patient MCW study of Pattern Computer's ProSpectral saliva scan reports 91% specificity and 44% sensitivity, with a path to 98% specificity claimed. FDA Grants Fast Track Designation to Erasca's Oral Pan-RAS Molecular Glue ERAS-0015 for Metastatic Pancreatic Adenocarcinomahttps://www.apoapenews.com/articles/fda-fast-track-eras-0015-pan-ras-glue-pancreatic/https://www.apoapenews.com/articles/fda-fast-track-eras-0015-pan-ras-glue-pancreatic/Mon, 24 Aug 2026 12:00:00 +0000OncologyFDA grants Fast Track designation to Erasca's oral pan-RAS molecular glue ERAS-0015 for metastatic pancreatic adenocarcinoma on seven-patient Phase 1 data. Elacestrant Plus Everolimus Delivers 8.3-Month Median PFS After CDK4/6 Inhibitor Progression in the ELEVATE Umbrella Studyhttps://www.apoapenews.com/articles/elevate-elacestrant-everolimus-er-positive-breast-cancer-pfs/https://www.apoapenews.com/articles/elevate-elacestrant-everolimus-er-positive-breast-cancer-pfs/Mon, 24 Aug 2026 12:00:00 +0000OncologyPhase 2 ELEVATE data: elacestrant plus everolimus gave a median PFS of 8.3 months in 50 ER+/HER2- breast cancer patients after CDK4/6 inhibitors. European Commission Approves Gilead's Trop-2 ADC Trodelvy Plus Keytruda for First-Line PD-L1-Positive Metastatic Triple-Negative Breast Cancerhttps://www.apoapenews.com/articles/ec-approves-trodelvy-keytruda-first-line-pdl1-tnbc/https://www.apoapenews.com/articles/ec-approves-trodelvy-keytruda-first-line-pdl1-tnbc/Mon, 24 Aug 2026 12:00:00 +0000ADCs & RadiopharmaEuropean Commission approves Trodelvy plus Keytruda for first-line metastatic triple-negative breast cancer at PD-L1 CPS 10 or higher, on ASCENT-04 data. Periductal Myxoid Stroma on the Diagnostic H&E Slide Identifies DCIS at Risk of Invasive Recurrence in the SweDCIS Trialhttps://www.apoapenews.com/articles/dcis-periductal-myxoid-stroma-swedcis-invasive-recurrence/https://www.apoapenews.com/articles/dcis-periductal-myxoid-stroma-swedcis-invasive-recurrence/Mon, 24 Aug 2026 12:00:00 +0000PathologyIn 711 SweDCIS patients, DCIS with at least 10% periductal myxoid stroma on H&E had 15.7% 20-year invasive recurrence versus 7.1%, JNCI reports. Sanofi to Lay Off 229 Blueprint Medicines Workers in Massachusetts, 13 Months After the $9.1 Billion Acquisitionhttps://www.apoapenews.com/articles/sanofi-229-blueprint-layoffs-cambridge-warn/https://www.apoapenews.com/articles/sanofi-229-blueprint-layoffs-cambridge-warn/Sat, 22 Aug 2026 12:00:00 +0000Business & RegulatoryAn Aug. 7 WARN filing shows Sanofi cutting 229 Blueprint Medicines jobs from October to June 2027 and closing two Cambridge sites after the $9.1B deal. Radiopharm Theranostics Clears Safety Review to Open 180 mCi Cohort in 177Lu-RAD202 HER2 Radioligand Trialhttps://www.apoapenews.com/articles/radiopharm-rad202-heat-cohort-4-180mci/https://www.apoapenews.com/articles/radiopharm-rad202-heat-cohort-4-180mci/Sat, 22 Aug 2026 12:00:00 +0000ADCs & RadiopharmaA safety committee cleared Radiopharm Theranostics to open the 180 mCi fourth cohort of its HER2-targeted 177Lu-RAD202 Phase 1 HEAT trial in Australia. Lustgarten Foundation Directs $22.8 Million to 18 Pancreatic Cancer Projects, Led by KRAS Interception and Early-Detection Trialshttps://www.apoapenews.com/articles/lustgarten-foundation-22-8-million-pancreatic-cancer-fy2026/https://www.apoapenews.com/articles/lustgarten-foundation-22-8-million-pancreatic-cancer-fy2026/Sat, 22 Aug 2026 12:00:00 +0000OncologyLustgarten Foundation puts $22.8 million into 18 pancreatic cancer projects in fiscal 2026, led by a first-in-human KRAS-inhibitor interception trial. China's NMPA Accepts Leads Biolabs' PD-L1/4-1BB Bispecific Opamtistomig for Review in Neuroendocrine Carcinomahttps://www.apoapenews.com/articles/leads-biolabs-opamtistomig-nmpa-nda-wclc/https://www.apoapenews.com/articles/leads-biolabs-opamtistomig-nmpa-nda-wclc/Sat, 22 Aug 2026 12:00:00 +0000Immuno-OncologyLeads Biolabs' opamtistomig NDA accepted by China's CDE for previously treated EP-NEC; a WCLC abstract adds a 65% first-line NSCLC response rate. Ipsen Completes Kartos Therapeutics Acquisition, Adding Phase III MDM2 Inhibitor Navtemadlin in Myelofibrosishttps://www.apoapenews.com/articles/ipsen-completes-kartos-acquisition-navtemadlin/https://www.apoapenews.com/articles/ipsen-completes-kartos-acquisition-navtemadlin/Sat, 22 Aug 2026 12:00:00 +0000Business & RegulatoryIpsen closed its Kartos Therapeutics purchase Aug. 21, paying $450M upfront for navtemadlin, an oral MDM2 inhibitor in Phase III for myelofibrosis. Merck and Moderna Report Positive Phase 3 Interim Readout for Individualized mRNA Therapy Intismeran in Resected Melanomahttps://www.apoapenews.com/articles/intismeran-interpath-001-phase-3-melanoma/https://www.apoapenews.com/articles/intismeran-interpath-001-phase-3-melanoma/Sat, 22 Aug 2026 12:00:00 +0000Immuno-OncologyINTerpath-001 met its recurrence-free and distant metastasis-free survival endpoints at interim analysis. No hazard ratios were released. FDA Issues a Third Complete Response Letter for Xspray Pharma's Amorphous Dasatinib Dasynochttps://www.apoapenews.com/articles/fda-third-crl-xspray-dasynoc-dasatinib/https://www.apoapenews.com/articles/fda-third-crl-xspray-dasynoc-dasatinib/Sat, 22 Aug 2026 12:00:00 +0000Business & RegulatoryThe FDA cited outstanding GMP observations at NerPharMa and asked for more commercial-scale batch data, six days before the Aug. 25 PDUFA date. FDA Grants Nuvation Bio's Mutant-IDH1 Inhibitor Safusidenib Fast Track Designation for IDH1-Mutant Gliomahttps://www.apoapenews.com/articles/fda-fast-track-safusidenib-idh1-mutant-glioma/https://www.apoapenews.com/articles/fda-fast-track-safusidenib-idh1-mutant-glioma/Sat, 22 Aug 2026 12:00:00 +0000OncologyFDA granted Fast Track to safusidenib in IDH1-mutant glioma on Aug. 20, 2026, as Nuvation Bio enrolls the 300-patient Phase 3 SIGMA maintenance trial. FDA Grants Accelerated Approval to Replimune's Oncolytic Viral Therapy Tudriqev for Anti-PD-1 Refractory Melanomahttps://www.apoapenews.com/articles/fda-approves-tudriqev-refractory-melanoma/https://www.apoapenews.com/articles/fda-approves-tudriqev-refractory-melanoma/Sat, 22 Aug 2026 12:00:00 +0000Immuno-OncologyAccelerated approval for Tudriqev with nivolumab rests on a 24.2% response rate in 91 evaluable patients, after two complete response letters. FDA Approves Orca Bio's Donor-Derived Regulatory T Cell Therapy Tregzi for Matched-Donor Transplant in Blood Cancershttps://www.apoapenews.com/articles/fda-approves-tregzi-orca-bio-treg-cell-therapy/https://www.apoapenews.com/articles/fda-approves-tregzi-orca-bio-treg-cell-therapy/Sat, 22 Aug 2026 12:00:00 +0000HematologyTregzi, from Orca Bio, is cleared for matched-donor transplant after Precision-T showed 78% chronic GVHD-free survival at one year versus 38%. Enhertu Improves Progression-Free Survival Over Pembrolizumab Plus Chemotherapy in First-Line HER2-Mutant NSCLC in DESTINY-Lung04https://www.apoapenews.com/articles/enhertu-destiny-lung04-first-line-her2-mutant-nsclc-pfs/https://www.apoapenews.com/articles/enhertu-destiny-lung04-first-line-her2-mutant-nsclc-pfs/Sat, 22 Aug 2026 12:00:00 +0000ADCs & RadiopharmaDESTINY-Lung04 met its primary endpoint: Enhertu improved PFS versus pembrolizumab plus platinum-pemetrexed in 454 first-line HER2-mutant NSCLC patients. European Commission Approves Johnson & Johnson's Teclistamab With Daratumumab for Relapsed or Refractory Multiple Myelomahttps://www.apoapenews.com/articles/ec-approves-teclistamab-daratumumab-myeloma/https://www.apoapenews.com/articles/ec-approves-teclistamab-daratumumab-myeloma/Sat, 22 Aug 2026 12:00:00 +0000HematologyEU approval covers adults with at least one prior therapy and rests on MajesTEC-3, which reported a hazard ratio of 0.17 for progression or death. Dizal Takes Adjuvant ZEGFROVY Data in Resected EGFR Exon 20 Insertion NSCLC to WCLC 2026https://www.apoapenews.com/articles/dizal-zegfrovy-sunvozertinib-wclc-2026-adjuvant/https://www.apoapenews.com/articles/dizal-zegfrovy-sunvozertinib-wclc-2026-adjuvant/Sat, 22 Aug 2026 12:00:00 +0000OncologyDizal will present adjuvant sunvozertinib data in resected stage IB-IIIB EGFR exon 20 insertion NSCLC and an anlotinib combination at WCLC 2026. Cytek Prevails on Three of Four Claims in Beckman Coulter Flow Cytometry Patent Trial, Will Contest $56M Awardhttps://www.apoapenews.com/articles/cytek-beckman-coulter-jury-verdict-flow-cytometry-patents/https://www.apoapenews.com/articles/cytek-beckman-coulter-jury-verdict-flow-cytometry-patents/Sat, 22 Aug 2026 12:00:00 +0000Business & RegulatoryA Delaware jury found Cytek did not infringe three of four Beckman Coulter patent claims but awarded $56M on the fourth under the doctrine of equivalents.