BREAST CANCER

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.

"Sacituzumab govitecan plus pembrolizumab [led to] improvement in PFS2...despite the crossover design of the trial," said Eleonora Teplinsky, MD.

A PD-1/TIGIT bispecific antibody plus T-DXd yielded pathologic complete responses, avoiding need for further chemotherapy.

"The key finding is that more axillary surgery in itself does not improve survival in these patients," said Jana de Boniface, MD, PhD.

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

Explore how genomic assays guide personalized early-stage ER+/HER2- breast cancer treatment, weighing Oncotype, MammaPrint, menopausal status, and chemo decisions.

The approval of the TROP2-directed ADC datopotamab deruxtecan is supported by results from the phase 3 TROPION-Breast02 trial.

The neoadjuvant and adjuvant FDA indications for T-DXd in HER2+ breast cancer are based on the DESTINY-Breast11 and DESTINY-Breast05 trials, respectively.

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 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.

Real-world data show community oncology care links to longer survival in metastatic breast cancer and NSCLC, beating national benchmarks.

A new Bayesian statistical framework uses the residual cancer burden score to better predict long-term survival in breast cancer trials beyond binary pCR.

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

MSK researchers found that BRCA2 mutations lower the barrier for RB1 loss, causing CDK4/6 inhibitor resistance.

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

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

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.