Sabrina Serani

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.

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.

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.