The third BLA submission for tabelecleucel follows 2 CRLs and includes updated ALLELE data with additional patients and longer follow-up.

A New England Journal of Medicine report describes complete hepatoblastoma regression in a 3-year-old treated with a novel immunotherapy.

Plinabulin plus docetaxel received fast track designation for pretreated nonsquamous NSCLC without actionable genomic alterations.

Meredith Pelster, MD, MSCI, discusses the biomarker-agnostic design of the phase 3 MAPKeeper 301 trial of atebimetinib in metastatic pancreatic cancer.

Alexander N. Shoushtari, MD, discusses the current role, benefits, and limitations of monitoring ctDNA in metastatic uveal melanoma.

Researchers at Wake Forest University School of Medicine identified a protein that may help breast cancer spread to the brain and evade immune defenses.

Benjamin Weinberg, MD, discusses the FDA approval of daraxonrasib, RASolute 302 survival data, safety considerations, and future RAS-targeted therapies in pancreatic cancer.

Moh’d Khushman, MD, discusses the rationale for investigating INCA33890 plus FOLFOX/bevacizumab in the phase 3 setting in patients with MSS/pMMR mCRC.

Jason Hafron, MD, discusses the emotional, clinical, and financial burden of false positive cancer screening results and improved risk stratification.

Rebecca Brown, MD, discusses how the NCCN guideline inclusion of brigatinib is changing clinical practice for NF2-related schwannomatosis.

Philip A. Philip, MD, discusses how tumor treating fields work and their role in locally advanced pancreatic cancer following the Optune Pax FDA approval.

Raajit K. Rampal, MD, PhD, discusses JAK inhibitor choice in cytopenic myelofibrosis, emerging combinations, and anemia-directed agents.

The sNDA for elinzanetant seeks FDA approval for moderate-to-severe vasomotor symptoms in women receiving endocrine therapy for HR-positive breast cancer.

The NMPA has approved of pirtobrutinib in treatment-naive and previously treated CLL/SLL.

Philip A. Philip, MD, discusses TTFields in pancreatic cancer and what phase 3 data has shown in locally advanced disease.

Roswell Park Comprehensive Cancer Center recognized members of its clinical, research and healthcare teams during the second annual Excellence Awards.

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Daiichi Sankyo and Merck withdrew the I-DXd BLA in ES-SCLC after FDA discussions found phase 2 IDeate-Lung01 data insufficient for accelerated approval.

Drs Park and Kasi discuss the rise of neoadjuvant immunotherapy in CRC management, framing how this shift fits into the context of larger paradigm changes.

Results from an early-stage clinical trial found encouraging outcomes in newly diagnosed pancreatic cancer that had spread to distant organs.

Brad S. Kahl, MD, discusses EA4181 findings, whether cytarabine is needed with BTK inhibition, and the future of chemotherapy-free care in mantle cell lymphoma

Drs Florez and Riess discuss the distinction between HER2 overexpression and HER2 mutations in non–small cell lung cancer.

MAPK drugs restore TSHR in aggressive thyroid tumors, helping CAR-T cell therapy see and control solid tumors again.

An FDA advisory committee voted in favor of the benefits of the Galleri MCED test outweighing its risks in patients 50 years of age and older.

Novel approaches to the use of AI in oncology may require discussion and ultimately modification of existing proprietary and regulatory barriers.

Erica L. Mayer, MD, MPH, discusses the FDA approval of camizestrant and the clinical role of the ctDNA-guided switch paradigm introduced by SERENA-6.

Shimoli Barot, MD, discusses PATINA data showing improved PFS with palbociclib-based maintenance in HR-positive, HER2-positive metastatic breast cancer.

Shimoli Barot, MD, considers how palbociclib maintenance could be sequenced with frontline T-DXd plus pertuzumab in HER2-positive metastatic breast cancer.

An IDMC recommended continuing a phase 2 minimal residual disease study of IMNN-001 without modification following a favorable safety review.

Clinicians and researchers are set to gather for the UCSF-cosponsored International Invasive Lobular Carcinoma Symposium.

SOT106 now holds both orphan drug and fast track designations across soft tissue sarcoma and osteosarcoma ahead of a first-in-human trial.

Read a refresh of breast cancer FDA news from August 2026, including an sNDA application in PIK3CA-mutant disease and a fast track designation.

Shailender Bhatia, MD, discusses ADAM trial design, key efficacy and safety findings, and treatment implications in Merkel cell carcinoma.

Mary Ann Anderson, MBBS, FRACP, FRCPA, PhD, explains how safety, resistance, and sequencing guide frontline therapy selection in CLL.

Lanreotide injection, a generic formulation referencing lanreotide, was approved by the FDA for GEP-NETs management.

The TrueBeam photon therapy system has been added to the Statesir Cancer Center at Atlantic Health CentraState Medical Center.

The addition of the β-catenin pathway inhibitor tegavivint to osimertinib produced deep responses in a phase 1b study in first-line EGFR-mutated NSCLC.

An observational analysis showed a long-term OS benefit with Orca-T in adult patients undergoing allogeneic transplantation for hematologic malignancies.

New research reveals how cancers carrying mutations in the p53 tumor-suppressor protein can hide those mutations from T cells.

Zev A. Wainberg, MD, discusses the phase 3 DAWN-303 trial of INCB161734 plus chemotherapy and the expanding role of KRAS inhibitors in pancreatic cancer.

Toon Van Gorp, MD, PhD, discusses key data with TUB-040 in platinum-resistant ovarian cancer and next steps for development.

Japan approved subcutaneous pembrolizumab and berahyaluronidase alfa across all indications for which intravenous pembrolizumab is approved in the country.

Mary Ann Anderson, MBBS, FRACP, FRCPA, PhD, discusses recent CLL approvals, BTK and BCL-2 inhibitor safety, and individualizing frontline therapy.

Jyoti Malhotra, MD, MPH on first-in-human clinical trials, lung cancer precision medicine in 2026, the disparities tension in drug development, and her move to Yale Cancer Center.

Lucy Gilbert, MD, MSc, FRCOG, discusses data from the ROSELLA trial of relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer.

CHMP has recommended EU approval of senaparib for advanced ovarian cancer based on FLAMES data.