Oncology & Hematology News

FDA approvals, breakthrough trials, and practice-changing oncology news.

FDA Approves SimpleScreen CRC — A Blood-Based Colorectal Cancer Screening Test for Average-Risk Adults — The FDA has approved SimpleScreen CRC, a blood-based colorectal cancer screening test developed by Freenome, for use in adults aged 45 and older who are at average risk for…
FIT-001 Phase 1a: Darlifarnib Plus Cabozantinib Achieves Up to 50% ORR and 13-Month Median PFS in Cabozantinib-Naïve Clear Cell RCC — Updated Phase 1a results from the FIT-001 trial (NCT06026410), presented at the 2026 Kidney Cancer Research Summit in Boston, demonstrated durable clinical activity of…
FDA Finalizes Three Guidances to Broaden Cancer Clinical Trial Eligibility — Performance Status, Washout Periods, and Lab Values — On July 27, 2026, the FDA's Oncology Center of Excellence (OCE) finalized three guidance documents designed to broaden eligibility criteria for cancer clinical trial enrollment.…
AAML1831: CPX-351 Inferior to Standard Daunorubicin/Cytarabine Induction in De Novo Pediatric AML — Phase III Report From the Children's Oncology Group — The Children's Oncology Group phase III AAML1831 trial (NCT04293562), reported online ahead of print in the Journal of Clinical Oncology on July 24, 2026, tested whether CPX-351…
TREASURE Trial: Consolidative Thoracic Radiotherapy Added to Atezolizumab Maintenance Increases Toxicity Without Improving Survival in Extensive-Stage SCLC — The phase 2 TREASURE randomised clinical trial (AIO-TRK-0320; NCT04462276) evaluated whether adding consolidative thoracic radiotherapy to atezolizumab maintenance therapy would…
FDA Grants Priority Review to Talazoparib Plus Enzalutamide for HRR-Mutated Metastatic Castration-Sensitive Prostate Cancer — The FDA has accepted and granted Priority Review to a supplemental New Drug Application for the combination of talazoparib (Talzenna, a PARP inhibitor) plus enzalutamide (Xtandi,…
MonumenTAL-6: Teclistamab Plus Talquetamab (Tec-Tal) Cuts Progression or Death by 89% in Relapsed/Refractory Myeloma — Topline results from the phase 3 MonumenTAL-6 study showed that dual-antigen bispecific immunotherapy — teclistamab (anti-BCMA) plus talquetamab (anti-GPRC5D), the "Tec-Tal"…
FDA Accepts NDA for Daraxonrasib in Pretreated Metastatic Pancreatic Cancer — The FDA accepted the New Drug Application for daraxonrasib (RMC-6236), an oral RAS(ON) multi-selective inhibitor, for patients with previously treated metastatic pancreatic…
Real-World Data Validates Serplulimab Outcomes in Extensive-Stage Small Cell Lung Cancer — Real-world outcomes for serplulimab in combination regimens have validated findings from the ASTRUM-005 trial in extensive-stage small cell lung cancer (ES-SCLC). Exploratory…
FDA Approves Zidesamtinib (Jideytro) for Pretreated ROS1-Positive NSCLC — The FDA approved zidesamtinib (Jideytro), a next-generation, brain-penetrant, ROS1-selective tyrosine kinase inhibitor, for adults with locally advanced or metastatic…
Ivonescimab Plus Chemotherapy Maintains Overall Survival Benefit in EGFR-Mutant NSCLC (HARMONi) — Updated results from the global phase 3 HARMONi trial show that ivonescimab — a first-in-class bispecific antibody simultaneously targeting PD-1 and VEGF — combined with…
First Published Phase I Results: Cevostamab Validates FcRH5 as a Target in Relapsed/Refractory Multiple Myeloma — The first published phase 1 clinical trial results for cevostamab — an investigational FcRH5×CD3 bispecific antibody — demonstrate that targeting FcRH5 is a feasible and valid…
Evolutionary Math Models: Precisely Timed Therapy Switches May Prevent Resistance and Improve Cure Rates — Researchers at City St George’s, University of London applied evolutionary theory to cancer treatment, showing with mathematical models that switching therapies before tumors…
First-in-Human mKRAS Vaccine Elicits Durable T-Cell Responses in High-Risk Pancreatic Cancer — A first-in-human trial has shown promising results for a peptide vaccine targeting KRAS variants in high-risk pancreatic ductal adenocarcinoma (PDAC). The vaccine demonstrated a…
Focal HIFU/Cryotherapy Demonstrates Durable 10-Year Control in Nonmetastatic Prostate Cancer — A comprehensive 10-year analysis of 3,477 patients found that focal therapy with high-intensity focused ultrasound (HIFU) or cryotherapy provides durable long-term disease…
IMNN-001 Immunotherapy Improves MRD and ctDNA Clearance in Frontline Ovarian Cancer (Phase 2) — IMUNON reported positive preliminary Phase 2 minimal residual disease (MRD) data for IMNN-001, an interleukin-12 DNA-mediated immunotherapy, added to frontline standard-of-care…
Emergency Department Cancer Diagnosis Linked to Higher Mortality Across 16 Cancer Types — A study published in the Journal of the National Cancer Institute (JNCI) found that cancers first diagnosed through an emergency department presentation carry a significantly…
Sensitive ddPCR Blood Test Detects Hidden Residual Pancreatic Cancer After Treatment — Researchers at Northwestern Medicine reported in Clinical Cancer Research (AACR) that digital droplet PCR (ddPCR) tracking KRAS mutations in circulating tumor DNA can detect…
Weill Cornell Maps Human Bone Marrow, Creating AI Tools to Decode Blood Cancers — Researchers at Weill Cornell Medicine completed a high-resolution spatial map of human bone marrow and built new computational tools that use it to uncover disease mechanisms in…
FDA Grants Fast Track Designation to Pelareorep Plus Checkpoint Inhibitor in Advanced Anal Cancer — The FDA granted Fast Track designation to pelareorep, an intravenously administered oncolytic reovirus, in combination with a checkpoint inhibitor for patients with inoperable,…
ASCERTAIN-V Data Support an All-Oral HMA Combination as a Frontline AML Option — New data from the ASCERTAIN-V program explore an all-oral hypomethylating agent (HMA) combination — oral decitabine/cedazuridine (ASTX727) plus venetoclax — as a frontline…
Study Redefines Functional High-Risk Multiple Myeloma in the Modern-Therapy Era — New research redefines functional high-risk (FHR) multiple myeloma for the era of anti-CD38 quadruplet induction and autologous stem cell transplantation. Rather than the…
NCCN Guidelines Incorporate ctDNA MRD Testing to Guide Adjuvant Immunotherapy in Bladder Cancer — Recent NCCN guideline updates now incorporate circulating tumor DNA (ctDNA) minimal residual disease (MRD) testing to help guide adjuvant immunotherapy decisions in bladder…
Radiation Omission Safe for Older Women With Stage I ER-Positive Breast Cancer After BCS — SEER Analysis — A large real-world SEER analysis of 50,845 patients aged 70 years or older with stage I ER-positive breast cancer treated with breast-conserving surgery (BCS) evaluated the…
Durvalumab With Radiation Therapy in Inoperable LA-NSCLC Ineligible for Concurrent ChemoRT — DART — The DART study investigated the efficacy and safety of durvalumab combined with radiation therapy in patients with inoperable locally advanced non-small cell lung cancer…
ASCO Updates Breast Cancer Follow-Up and Surveillance Guideline — ASCO has released an updated guideline for the follow-up and surveillance of patients after primary treatment for breast cancer. The update provides evidence-based…
Pembrolizumab Monotherapy Beats Platinum-Doublet Chemotherapy for PFS in Frontline dMMR Advanced/Recurrent Endometrial Cancer — KEYNOTE-C93 — Merck reported that the phase 3 KEYNOTE-C93 trial (GOG-3064 / ENGOT-en15) met its primary endpoint of progression-free survival: first-line single-agent pembrolizumab produced a…
ENDURANCE (E1A11): Fixed 2-Year Lenalidomide Maintenance Equals Indefinite Therapy in Transplant-Ineligible Newly Diagnosed Multiple Myeloma — No Overall Survival Benefit, More Toxicity With Continuous Treatment — The ECOG-ACRIN ENDURANCE phase 3 trial (E1A11), published in the New England Journal of Medicine on July 15, 2026, provides the first randomised evidence on the optimal duration…
New JCO Guidance on Tobacco Treatment in Cancer Care — The Journal of Clinical Oncology has published new guidance on implementing effective tobacco treatment for patients with cancer. This comprehensive document outlines strategies…
CRISPR-Cas13 mRNA Engineering Restores Immune Visibility of Prostate Tumors by Repairing SPSB1 mRNA Tail, Sensitizing 'Immune-Cold' Cancers to Checkpoint Therapy — Researchers at Duke University School of Medicine (lead institution) and the University of Rochester Medical Center have engineered a CRISPR-Cas13 tool that reactivates immune…
FDA Approves Gedatolisib (Revtorpyk) for HR+/HER2-, PIK3CA Wild-Type Advanced Breast Cancer — The FDA approved gedatolisib (Revtorpyk), the first and only therapy that inhibits all four class I PI3K isoforms (α, β, δ, γ) plus mTOR complexes mTORC1 and mTORC2, for…
FDA Approves Gedatolisib (Revtorpyk) With Fulvestrant ± Palbociclib for PIK3CA-Wild-Type HR+/HER2− Advanced Breast Cancer — VIKTORIA-1 — On July 14, 2026, the FDA approved gedatolisib (Revtorpyk), a pan-PI3K/mTOR inhibitor, in combination with fulvestrant — with or without palbociclib — for adults with hormone…
Rituximab Maintenance Added to Ibrutinib-Containing Therapy in Younger, Untreated Mantle Cell Lymphoma — TRIANGLE Trial — The phase 3 TRIANGLE trial evaluated the role of rituximab maintenance within an ibrutinib-containing treatment strategy for previously untreated, younger, transplant-eligible…
Clinical and Psychological Outcomes After Monoclonal Gammopathy Screening — iStopMM Population-Based Study and Randomized Follow-Up Trial — The iStopMM (Iceland Screens, Treats, or Prevents Multiple Myeloma) study is a nationwide, population-based program that offered screening for monoclonal gammopathy of…
Avatrombopag Shows Promise in Persistent Chemotherapy-Induced Thrombocytopenia in GI Cancers — Phase II ACT-GI Trial — The phase II ACT-GI trial evaluated the oral thrombopoietin receptor agonist avatrombopag versus placebo for persistent chemotherapy-induced thrombocytopenia (CIT) in patients…
Phase III ENHANCE Study Evaluates Magrolimab Plus Azacitidine in Higher-Risk MDS — The phase III ENHANCE study investigated magrolimab, a CD47 inhibitor, in combination with azacitidine versus placebo plus azacitidine for patients with previously untreated…
ASCO Publishes Updated Living Guideline for Systemic Treatment of Ovarian Cancer Recurrence — ASCO released Version 2026.1.0 of its Living Guideline on the systemic treatment of recurrent ovarian cancer, providing updated evidence-based recommendations. The guideline…
FDA Expands PADCEV + Keytruda to All Muscle-Invasive Bladder Cancer Patients — EV-304 Trial Removes Cisplatin Eligibility Barrier — On July 10, 2026, the FDA expanded the perioperative approval of enfortumab vedotin-ejfv (PADCEV) with pembrolizumab (Keytruda) to include cisplatin-eligible patients with…
FDA Approves Isatuximab (Sarclisa Escena) Subcutaneous via On-Body Injector — First Anticancer Drug With Wearable Delivery Device for Multiple Myeloma — On July 9, 2026, the FDA approved isatuximab-irfc (Sarclisa Escena, Sanofi) for subcutaneous injection via an on-body delivery system (OBDS) — a wearable device worn on the…
WHO Warns New Cancer Cases Could Nearly Double by 2050 Without Urgent Action — The World Health Organization, in its Global Status Report on Cancer 2026 (developed jointly with the International Agency for Research on Cancer, IARC), warned that annual new…
¹⁷⁷Lu-Edotreotide Demonstrates Significantly Superior Progression-Free Survival vs. Everolimus in Advanced GEP-NETs — Phase 3 COMPETE Trial Published in The Lancet — The Phase 3 COMPETE trial, published in The Lancet, demonstrated that investigational ¹⁷⁷Lu-edotreotide (ITM-11, ITM Isotope Technologies Munich) significantly improved…
Dual Checkpoint Blockade (Anti-PD-1 + Anti-CTLA-4) Overcomes Immune Exclusion in NSCLC Brain Metastases via Tertiary Lymphoid Structure Formation — A translational study published in Nature Communications demonstrated that combined anti-PD-1 plus anti-CTLA-4 blockade overcomes the immune-excluded phenotype that characterizes…
European Commission Approves Epcoritamab + Lenalidomide + Rituximab as First Chemotherapy-Free Bispecific Combination for Relapsed/Refractory Follicular Lymphoma — The European Commission approved epcoritamab (Tepkinly, AbbVie/Genmab) combined with lenalidomide and rituximab (R²) for adults with relapsed or refractory follicular lymphoma…
ESTRO Clinical Practice Consensus Recommendations: How to Deliver a Focal Boost in Prostate Cancer Radiotherapy — The European Society for Radiotherapy and Oncology (ESTRO) has published clinical practice consensus recommendations on the optimal delivery of focal dose escalation to the…
First-in-Human Personalized Neoantigen-Pulsed Dendritic Cell Vaccine More Than Doubles Progression-Free Survival in Newly Diagnosed Glioblastoma — A Phase Ib trial published in Nature Communications demonstrated that personalized neoantigen-pulsed autologous dendritic cell (DC) vaccination combined with standard…
Adjuvant Chemoradiotherapy vs. Completion Total Mesorectal Excision After Local Excision for Early Rectal Cancer — TESAR Trial — The multicentre, randomised, controlled, phase 3 TESAR trial tested whether organ-preserving adjuvant chemoradiotherapy is non-inferior to completion total mesorectal excision…
IDH1 R132H Peptide Vaccine Shows Durable 8-Year Survival Benefit in IDH1-Mutant Glioma — Final NOA16 Analysis — Final analysis of the phase 1 NOA16 trial (German Cancer Research Center / Heidelberg University Hospital), published in Nature Cancer, demonstrated that the IDH1 R132H peptide…
FDA Expands Casgevy CRISPR Gene Therapy to Children as Young as Age 2 — Landmark Milestone for CRISPR Medicine — On July 1, 2026, the FDA approved an expanded indication for Casgevy (exagamglogene autotemcel; exa-cel), the world's first approved CRISPR-based medicine, lowering the eligible…
FDA Approves Tregzi — First Allogeneic Regulatory T Cell Therapy — to Prevent Chronic GVHD After Stem Cell Transplant — The FDA approved Tregzi (allogeneic regulatory T cell–based immunotherapy with HSPC and T cells, Orca Bio) for adult and pediatric patients (≥2 years) with hematologic…
Ozelle Debuts O-Cyte 1 at ADLM 2026 — AI-Powered Complete Blood Morphology Analyzer Bridges High-Throughput Speed and Morphological Detail — Ozelle announced the upcoming global debut of O-Cyte 1, its next-generation automated hematology analyzer, ahead of its showcase at the Association for Diagnostics & Laboratory…
FDA Approves Palbociclib + Trastuzumab (± Pertuzumab) + Endocrine Therapy for HR+/HER2+ Metastatic Breast Cancer Maintenance — PATINA Trial — On June 24, 2026, the FDA approved palbociclib (Ibrance, Pfizer) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment…
FDA Approves Trodelvy as First-Line Therapy for Metastatic Triple-Negative Breast Cancer — First ADC Approved in Front-Line TNBC — On June 24, 2026, the FDA approved sacituzumab govitecan (Trodelvy, Gilead) for two first-line indications in locally advanced/metastatic triple-negative breast cancer (mTNBC):…
FDA Approves Capivasertib + Abiraterone for PTEN-Deficient Metastatic Hormone-Sensitive Prostate Cancer — CAPItello-281 — On June 12, 2026, the FDA approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve…
FDA Approves Belzutifan + Pembrolizumab for Adjuvant Clear Cell RCC — First PD-1 + HIF-2α Inhibitor Combination — On June 12, 2026, the FDA approved pembrolizumab (Keytruda) and pembrolizumab + berahyaluronidase alfa-pmph (Keytruda QLEX), each in combination with belzutifan (Welireg), for…
Ziftomenib + 7+3 Chemotherapy Achieves 96% Complete Remission in Frontline NPM1-Mutated AML — KOMET-007 Long-Term Update — Long-term follow-up from the KOMET-007 phase 1/2 trial demonstrated that ziftomenib — an oral menin inhibitor — combined with standard 7+3 induction chemotherapy (cytarabine +…
Stem Cell Transplantation More Cost-Effective Than Gene Therapy for Sickle Cell Disease — Blood Analysis — A cost-effectiveness analysis published in Blood and highlighted by the American Society of Hematology (June 2, 2026) found that stem cell transplantation is the most…
HARMONi-6: Ivonescimab + Chemotherapy Improves Overall Survival in Advanced Squamous NSCLC vs PD-1 + Chemotherapy — The phase 3 HARMONi-6 trial demonstrated that ivonescimab — a bispecific antibody simultaneously targeting PD-1 and VEGF — plus chemotherapy significantly improved overall…
15-Year Final Outcomes From SOFT and TEXT Confirm Durable Survival Benefit of Ovarian Function Suppression in Premenopausal HR+ Breast Cancer — Final 15-year outcomes from the combined SOFT and TEXT phase III trials, published in Annals of Oncology, confirm that ovarian function suppression (OFS) with endocrine therapy…
PROTEUS: Perioperative Apalutamide + ADT Improves Metastasis-Free Survival in High-Risk Localized Prostate Cancer — The final analysis of the phase 3 PROTEUS trial, presented in the Plenary Session at the 2026 ASCO Annual Meeting (Abstract LBA1) and published simultaneously in the New England…
LIBRETTO-432: Adjuvant Selpercatinib Improves Event-Free Survival in Resected RET Fusion–Positive Early-Stage NSCLC — Primary results of the phase 3 LIBRETTO-432 trial, presented at the 2026 ASCO Annual Meeting (Abstract LBA3) and published in the New England Journal of Medicine, showed that…