Sabrina Serani

Hafnium oxide nanoparticle radioenhancer adds safely to standard chemoradiotherapy in unresectable stage III NSCLC, showing deep responses and promising early efficacy.

FDA clears HARMONIC trial changes as LP-300 targets EGFR L858R lung cancer after TKI failure, aiming for longer dosing and lower toxicity.

Preview ASCO 2026 late-breaking cancer trials—from TNBC ADC survival gains to lung, liver, prostate and myeloma readouts shaping care.

FDA fast-tracks sevabertinib for first-line HER2-mutant metastatic NSCLC, spotlighting strong SOHO-01 responses and manageable safety.

Gedatolisib moves frontline in HR+/HER2– metastatic breast cancer, adding endocrine-sensitive patients and testing triplets vs ribociclib to boost PFS.

FDA fast tracks RPTR-1.201, a TCR bispecific immunotherapy for advanced triple-negative breast cancer, as RaPTR-101 tests safety and early efficacy.

VIKTORIA-1 shows gedatolisib plus fulvestrant, with or without palbociclib, boosts PFS after CDK4/6 therapy in PIK3CA-mutant breast cancer.

The FDA has approved the first PROTAC in any indication, supported by phase 3 VERITAC-2 data.

The FDA's Oncologic Drugs Advisory Committee voted in favor 7 to 1 that benefits of capivasertib outweighed risks.

The FDA's ODAC voted 6-3 against camizestrant for HR+/HER2– breast cancer, citing concerns over the SERENA-6 trial design and a lack of overall survival data.

FDA accepted the NDA for zipalertinib to treat previously treated metastatic NSCLC with EGFR exon 20 insertion mutations. Target action date: 2/27/27.

NCCN now recommends taletrectinib for ROS1+ NSCLC with brain metastases, citing high intracranial response rates in TKI-naive and pretreated patient cohorts.

Bayesian modeling links residual cancer burden shifts to survival, helping neoadjuvant breast cancer trials and FDA approvals predict real benefit.

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.