Sabrina Serani

Afuresertib plus fulvestrant cuts progression risk in HR+/HER2– metastatic breast cancer with PI3K/AKT/PTEN alterations, with manageable safety.

Dr Christine Bestvina discusses EGFR treatment shifts, KRAS trial data, and expanding clinical trial access for community oncologists.

NCCN adds mammogram AI risk scoring; a 1.7% five‑year cutoff now prompts earlier screening and optional MRI/ultrasound.

FDA grants priority review to ifinatamab deruxtecan for extensive-stage SCLC based on phase 2 IDEATE-Lung01 data. PDUFA date set for October 10, 2026.

The DAISY trial shows that HER2DX and DNADX genomic assays can predict T-DXd response in metastatic breast cancer by measuring HER2 levels and DNA instability.

FDA accepted the NDA for 18F-FET, a PET imaging agent designed to distinguish glioma progression from treatment-induced changes in brain cancer.

FDA grants orphan drug designation to rhenium (186Re) obisbemeda for pediatric glioma and ependymoma, supported by the phase 1/2a ReSPECT-PBC clinical trial.

Nuvalent has submitted an NDA to the FDA for neladalkib, a brain-penetrant ALK-selective TKI for pretreated advanced ALK-positive NSCLC.

Study finds risk-reducing mastectomy in BRCA1/2 carriers significantly cuts cancer risk but offers no overall survival benefit over intensive surveillance.

The FDA granted fast track designation to PAS-004, a macrocyclic MEK inhibitor, for NF1-associated plexiform neurofibromas causing significant morbidity.

Dr Dale Shepard of Cleveland Clinic discusses the PYNNACLE trial results for rezatapopt, the first successful small-molecule reactivation of mutant p53.

The FDA granted breakthrough therapy designation to plixorafenib for adult patients with BRAF V600E–mutated high-grade glioma, based on data from a completed phase 1/2a trial and the ongoing phase 2 FORTE basket study.

Discover the critical Q2 2026 FDA decisions for Dato-DXd in TNBC and Orca-T in blood cancers, set to transform survival outcomes and precision oncology care.

Phase 2 TBCRC049 trial results show tucatinib triplet therapy improves survival in HER2+ breast cancer patients with leptomeningeal metastasis.

Phase 2b data show RAD101 amino acid PET hits 90% concordance, helping distinguish brain metastasis recurrence from pseudoprogression and necrosis.

FDA fast tracks TRI-611, an ALK molecular glue degrader for refractory ALK+ NSCLC. Phase 1/2 trial targets resistance after 2 or more TKIs.

New first-line ES-SCLC data show iza-bren plus serplulimab drives 88% responses and manageable safety, setting up phase 3 trials.

The proposed biosimilar demonstrated clinical equivalence to the reference product in overall response rate at 18 weeks, with a comparable safety profile, supporting regulatory submissions.

Phase 1 data show that setidegrasib degrades KRAS G12D, delivering durable NSCLC responses with manageable safety and biomarker-linked benefit as phase 3 plans advance.

Phase 3 data show oral sunvozertinib beats platinum chemo in EGFR exon 20ins NSCLC, boosting PFS and responses with tolerable safety.

ELCC 2026 spotlights lung cancer breakthroughs—ADCs, EGFR combo sequencing, HER2 TKIs and SCLC bispecifics—reshaping treatment choices.

FDA grants orphan drug status to irinotecan ChemoSeed implant for high-grade gliomas, enabling sustained local brain tumor therapy and accelerating pivotal trials.

Aglatimagene besadenovec intratumoral gene therapy plus valacyclovir shows durable survival in ICI-resistant advanced NSCLC, fueling pivotal phase 3 plans.

Digital twin modeling plus metabolomics predicts which drugs can starve glioblastoma, enabling faster, personalized treatment testing.

Data presented at ESMO Targeted Anticancer Therapies Congress 2026 support ongoing phase 3 evaluation.

Phase 3 NSCLC study of eftilagimod alfa with pembrolizumab and chemo stops early after futility review, raising questions about LAG-3 strategy.

Blood biomarkers reveal which glioblastoma patients respond to Delta-24-RGD oncolytic virus plus IFN-γ, guiding personalized dosing and survival.

Breast cancer care shifts fast: ADCs reach HER2-low, neoadjuvant regimens evolve, and ctDNA MRD testing sparks 2026’s debate.

Gedatolisib plus fulvestrant, with or without palbociclib, boosts PFS in HR+/HER2− PIK3CA WT breast cancer after CDK4/6.