FDA Approves Pivekimab sunirine-pvzy for Rare Blood Cancer BPDCN

Drug Approvals /

The FDA has approved Pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive blood cancer. The drug is the first CD123-targeting antibody-drug conjugate that can be started in an outpatient setting. It is administered intravenously every three weeks based on actual body weight. Approval was supported by results […]

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B7-H3–Targeted ADCs Show Promising Early Results Across Multiple Solid Tumors

Treatment /

B7-H3 is emerging as one of the most promising targets in cancer therapy because it is highly expressed across many solid tumors while remaining limited in normal tissues. Several antibody-drug conjugates (ADCs) targeting B7-H3 are now showing encouraging early results in lung, prostate, and gynecologic cancers. In small cell lung cancer, Ifinatamab deruxtecan received FDA

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FDA Approves Durvalumab Plus BCG for High-Risk Non–Muscle-Invasive Bladder Cancer

Drug Approvals /

The FDA has approved Durvalumab (Imfinzi) plus BCG for adults with BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC). The approval is based on the phase 3 POTOMAC trial, which compared durvalumab plus BCG against standard BCG therapy alone. The combination significantly improved disease-free survival, reducing the risk of recurrence or progression by 32% (HR 0.68; P

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Quantitative ICG Imaging Improves Perfusion Assessment and Reduces Leak Risk in Colorectal Cancer Surgery

News /

A study evaluated whether quantitative analysis of indocyanine green (ICG) fluorescence imaging could improve assessment of bowel perfusion during colorectal cancer surgery and reduce the risk of anastomotic leakage, a serious postoperative complication caused by poor blood supply at the surgical connection site. The study included 80 patients and used near-infrared imaging to assess tissue

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Daraxonrasib Shows Practice-Changing Potential in Metastatic Pancreatic Cancer as Expanded Access Demand Surges

Treatment /

Daraxonrasib (RMC-6236), an investigational RAS(ON) inhibitor, is generating major attention in metastatic pancreatic ductal adenocarcinoma (PDAC) after positive Phase 3 RASolute 302 trial results showed significant improvements in overall survival and progression-free survival compared with standard chemotherapy. The drug has received FDA breakthrough therapy and orphan drug designations for previously treated metastatic PDAC. The results

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Zanidatamab Regimens Improve Survival in HER2-Positive Gastroesophageal Cancer Phase 3 Trial

Treatment /

The Phase 3 HERIZON-GEA-01 trial showed that zanidatamab-hrii (Ziihera)-based regimens significantly improved outcomes for patients with previously untreated HER2-positive advanced gastric, gastroesophageal junction, and esophageal cancers. The study enrolled 914 patients who received either zanidatamab plus tislelizumab and chemotherapy, zanidatamab plus chemotherapy, or standard trastuzumab plus chemotherapy. At a median follow-up of 25.9 months, both

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FDA Approves Decnupaz for Rare BPDCN Blood Cancer Following CADENZA Trial Results

Drug Approvals /

The FDA has approved pivekimab sunirine-pvzy (Decnupaz) for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare blood cancer. The first-in-class antibody-drug conjugate targets CD123 and delivers a DNA-damaging payload directly to cancer cells. Approval was based on the Phase 1/2 CADENZA trial. In treatment-naive patients, the complete remission rate reached 69.7%, with a

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RD118 CAR T Therapy Shows High Response Rates in Advanced Multiple Myeloma Phase 1 Trial

Clinical Trails /

A Phase 1 trial of RD118, a novel fully human anti-GPRC5D CAR T-cell therapy, showed strong and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma. The study enrolled 18 patients, many with high-risk disease, including prior BCMA CAR T failure. With a median follow-up of 17 months, the overall response rate

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TALAPRO-2 Analysis Supports rPFS as Surrogate for Survival in Metastatic Prostate Cancer

Treatment /

A new post hoc analysis of the phase 3 TALAPRO-2 trial found that radiographic progression-free survival (rPFS) strongly correlates with overall survival (OS) in first-line metastatic castration-resistant prostate cancer (mCRPC). The analysis evaluated patients treated with Talazoparib plus Enzalutamide or enzalutamide alone and showed consistent moderate-to-strong correlations across all major patient groups. The strongest association

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Immunotherapy Expands Into Earlier Treatment for High-Risk Cutaneous Squamous Cell Carcinoma

Immunotherapy /

Cutaneous squamous cell carcinoma (CSCC) is becoming increasingly defined by personalized treatment decisions based on whether tumors are surgically removable. Unlike basal cell carcinoma, which grows slowly and rarely spreads, CSCC is more aggressive and can invade nerves, lymph nodes, and distant organs, especially in immunosuppressed patients. For unresectable or metastatic disease, FDA-approved anti–PD-1 immunotherapies

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