Jordyn Sava is an editor for Targeted Oncology.
FDA Oks Penpulimab for First-Line Non-Keratinizing Nasopharyngeal Carcinoma
The FDA has approved penpulimab with chemotherapy for first-line recurrent/metastatic non-keratinizing nasopharyngeal carcinoma and alone after prior treatment.
FDA Grants Breakthrough Designation for EvoLiver in HCC
EvoLiver, a blood test that detects early-stage liver cancer with high accuracy, has gained breakthrough device designation from the FDA.
FDA Clears Phase 1 Study of TGW101 for Advanced Solid Tumor Treatment
Phase 1 trial of TGW101 in advanced solid tumors is enrolling to assess safety and pharmacokinetics and define the maximum tolerated dose in up to 50 patients.
TCMCB07 Enters Phase 2 for Weight Loss in Stage IV Colorectal Cancer
Following promising phase 1 data, TCMCB07 is being further evaluated in a phase 2 trial for the treatment of patients with stage IV colorectal cancer.
AUA 2025: A Sneak Peek for Community Oncologists/Urologists
At AUA 2025, experts will present on novel bladder cancer therapies, advanced renal cell carcinoma comparisons, frailty in prostate cancer, and more.
Exploring HIFU in Early to Intermediate Prostate Cancer Treatment
Alexander Kenigsberg, MD, discusses a new nonsurgical, robotic-focused ultrasound procedure for prostate cancer.
Sacituzumab Govitecan Plus Pembrolizumab Improves PFS in PD-L1+ TNBC
ASCENT-04 data showed sacituzumab govitecan plus pembrolizumab improved progression-free survival in PD-L1+ metastatic triple-negative breast cancer.
Leighl Covers PALOMA-3 Trial of SC Amivantamab in NSCLC
Natasha Leighl, MD, MMSc, BSc, discussed key findings from the PALOMA-3 trial for a community oncologist audience.
Bria-IMT Plus Retifanlimab Shows Promising Survival in HR+ Breast Cancer
Phase 2 data suggest a survival benefit with Bria-IMT and retifanlimab in heavily pretreated HR-positive metastatic breast cancer, outperforming historical controls.
FDA Clears IND Application for CLD-201 in Solid Tumors
The FDA has granted clearance to an investigational new drug application for CLD-201 for solid tumor treatment, based on preclinical findings.
Well-Tolerated TLX101 Shows Efficacy in Recurrent Glioma
Preliminary results from the phase 2 IPAX-Linz study show encouraging efficacy and a favorable safety profile for TLX101 in recurrent high-grade glioma.
FDA to Review Nogapendekin Alfa in Bladder Cancer and Lymphopenia
A supplemental biologics license application has been submitted to the FDA for nogapendekin alfa plus Bacillus Calmette-Guérin in papillary non-muscle invasive bladder cancer.
Predicting Palbociclib Outcomes in Breast Cancer Using Deep Learning
Xiaojie Zhang, MD, and Akshat Singhal, PhD, discuss their research leveraging deep learning to predict how patients with ER+/HER2- breast cancer will respond to palbociclib.
Novel Radioenhancer JNJ-1900 Shows Potential Across Cancers
Jared Weiss, MD, discussed the mechanism of action of JNJ-1900 and the preliminary data presented at the 2025 European Lung Cancer Congress.
Savolitinib/Osimertinib Yields Durable Responses in EGFR-Mutated, MET+ NSCLC
The phase 2 SAVANNAH trial of savolitinib plus osimertinib has demonstrated the combination’s efficacy and safety in EGFR-mutated NSCLC.
SGX301 Shows Rapid and Durable Responses in Early-Stage CTCL
SGX301 has shown rapid and sustained benefit in early cutaneous T-cell lymphoma in an investigator-initiated study, with good safety.
FDA Backs Darovasertib Phase 3 Trial Design in Uveal Melanoma
Following a recent Type D meeting with the FDA, a phase 3 clinical trial design for darovasertib in primary uveal melanoma has been announced.
First Patient Receives KSQ-004EX for Advanced Cancer
A phase 1/2 trial of CRISPR-engineered eTIL therapy KSQ-004EX for advanced solid tumors has dosed its first patient.
Gene Expression Test Accurately Predicts Low SLN Positivity Risk in Melanoma
The DecisionDx-Melanoma test accurately identifies low sentinel lymph node risk in melanoma, according to the DECIDE study.
COA Advocates for Biomarker Testing Access, Physician Autonomy in Cancer Care
Nicolas Ferreyros discussed central ideas from the Community Oncology Alliance to optimize cancer care in community oncology settings.
Tarlatamab Shows Significant OS Improvement in Post-Platinum SCLC
Tarlatamab outperformed chemotherapy when used for the treatment of patients with small cell lung cancer in the phase 3 DeLLphi-304 trial.
FDA Approves Nivolumab/Ipilimumab in First-Line Hepatocellular Cancer
Findings from the CheckMate 9DW trial support the FDA approval of nivolumab and ipilimumab in unresectable hepatocellular carcinoma
CT-95 Phase 1 Trial Enrolls and Doses First Patient With MSLN+ Advanced Cancer
A phase 1 open-label trial is underway, evaluating the safety and efficacy of CT-95 in patients with mesothelin-expressing advanced solid tumors.
Teclistamab Combo Yields Deep Responses in Newly Diagnosed Myeloma
Marc Raab, MD, PhD, discussed the MajesTEC-5 trial of teclistamab plus standard myeloma therapies in transplant-eligible newly diagnosed multiple myeloma.
FDA Greenlights Bevacizumab Biosimilar Across Cancer Types
The FDA has approved bevacizumab-nwgd, a biosimilar to bevacizumab, for intravenous use across multiple cancer types.
FDA Awards Full Approval to Larotrectinib in NTRK+ Solid Tumors
The FDA has fully approved larotrectinib for adult and pediatric patients with solid tumors that harbor an NTRK gene fusion.
Safety Committee Backs PH-762 Dose-Escalation in Skin Cancer Trial
A phase 1b trial is evaluating PH-762 for the treatment of cutaneous squamous cell carcinoma, melanoma and Merkel cell carcinoma.
FDA Clears ZEISS INTRABEAM 700 for IORT in Cancer Surgery
The FDA has granted 501(k) clearance to ZEISS INTRABEAM 700, a robotic-assisted platform designed to enhance intraoperative radiation therapy.
FDA Approves Nivolumab/Ipilimumab Combo in MSI-H/dMMR mCRC
Based on data from the phase 3 CheckMate-8HW trial, the combination of nivolumab and ipilimumab has been approved by the FDA in metastatic colorectal cancer.
FDA Clears IND Application for ST-001 in SCLC
ST-001, an intravenous nanoformulation of fenretinide, will be evaluated in a phase 1a/1b small cell lung cancer trial.