Sabrina Serani

FDA clears US enrollment for ateganosine plus cemiplimab in third-line NSCLC, testing telomere-targeting therapy after checkpoint and chemo failure.

FDA fast-tracks VS-7375, an oral KRAS G12D inhibitor, opening new hope for pretreated advanced NSCLC and fueling pivotal trials.

FDA fast-tracks TER-2013, an oral AKT1-selective inhibitor, for HR+/HER2– advanced breast cancer with AKT/PI3K/PTEN alterations.

FDA clears automated PD-L1 22C3 testing on Dako Omnis for 4 more tumors, streamlining labs and guiding Keytruda therapy decisions.

The FDA approved Lupin and Natco’s generic eribulin mesylate for pretreated metastatic breast cancer and unresectable or metastatic liposarcoma.

"The VIKTORIA-1 trial validates the PAM pathway as a molecular driver in hormone receptor–positive, HER2-negative advanced breast cancer, regardless of PIK3CA mutation status," said Sara Hurvitz, MD.

“The results from this phase 3 study support iza-bren as a new standard of care for patients with pretreated metastatic triple-negative breast cancer,” said Jiong Wu, MD, PhD.

FDA fast-tracks oral SERD giredestrant for early ER+/HER2- breast cancer after phase 3 shows 30% fewer invasive recurrences.

“In this interim analysis…the response rate with the zelenectide pevedotin and pembrolizumab [was] promising, supporting its benefit-risk profile and supporting…the optimized dosing," said Yohann Loriot, MD, PhD.

Phase 3 NEOTORCH shows perioperative toripalimab plus platinum chemo boosts event-free survival and responses in resectable stage II–III NSCLC.

FDA grants priority review to neladalkib for post-TKI ALK+ NSCLC, aiming to beat resistance and brain metastases; decision due Nov 27, 2026.

FDA extends camizestrant review as ctDNA-guided ESR1 switch sparks debate; new analyses debut at ASCO while Europe advances approval.

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.