MedPath

Tagged News

VCU Massey Becomes First Virginia Center to Offer Robotic HIFU for Prostate Cancer Treatment

Oncology
  • VCU Massey Comprehensive Cancer Center has become the first institution in Virginia to offer robotic high-intensity focused ultrasound (HIFU) using the Focal One system for prostate cancer treatment.
  • The noninvasive procedure takes approximately one to one-and-a-half hours and allows patients to return home the same day while preserving key structures related to erectile function and continence.
  • HIFU offers a less morbid alternative to surgery and radiation for intermediate-risk prostate cancer patients, with studies showing about 25% may need repeat ablation and 20-30% may progress to surgery or radiation within five years.
  • The technology addresses a significant clinical gap for patients with prostate cancer that is not aggressive enough for active surveillance but not severe enough to warrant immediate radical treatment.

Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression

Monoclonal AntibodyDrug ApprovalOncology
  • First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
  • The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
  • Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03088540CompletedPhase 3
Regeneron Pharmaceuticals
Posted 5/29/2017

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614CompletedPhase 3
Regeneron Pharmaceuticals
Posted 3/6/2018

Nusano Secures Major Supply Agreements with Ratio Therapeutics and Clarity Pharmaceuticals to Address Critical Radioisotope Shortage

Oncology
  • Nusano has entered into long-term supply agreements with Ratio Therapeutics and Clarity Pharmaceuticals to provide critical radioisotopes including copper-64, lutetium-177, and actinium-225 for cancer diagnostics and therapeutics.
  • The agreements address significant supply constraints in the radiopharmaceutical market, with Nusano's proprietary platform capable of producing over 1,000 curies of copper-64 daily from its upcoming Utah facility.
  • These partnerships position both pharmaceutical companies to advance their clinical pipelines, with Clarity's SAR-bisPSMA diagnostic ready for commercial rollout and Ratio's FAP-targeted radiotherapy entering clinical trials this year.

Kyowa Hakko Kirin Partners with InveniAI to Accelerate Drug Repurposing Using AI Technology

OncologyAIDrug Discovery
  • Kyowa Hakko Kirin has signed a partnership with AI company InveniAI to use their AlphaMeld technology for discovering new therapeutic applications for existing pipeline drugs.
  • The collaboration focuses on maximizing R&D value in oncology, nephrology, and immunology by identifying alternate uses for drugs including mogamulizumab, istradefylline, and entinostat.
  • This partnership represents part of a growing trend where pharmaceutical companies are leveraging AI platforms to reduce development costs and accelerate time to market for drug candidates.

Balancing Efficacy and Cost Sustainability in Modern CLL Treatment: Insights from Dr. Pierluigi Porcu

Oncology
  • Clinicians treating chronic lymphocytic leukemia (CLL) face growing challenges in balancing clinical efficacy with long-term cost sustainability, requiring a holistic approach to patient care.
  • Dr. Pierluigi Porcu emphasizes that effective CLL management requires understanding disease risk, patient comorbidities, and practice environment constraints including payer considerations.
  • Despite its importance, value-based care adoption remains insufficient in oncology, with challenges in defining and measuring value across patient outcomes, quality of life, and treatment costs.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma

NCT03710603Active, Not RecruitingPhase 3
Stichting European Myeloma Network
Posted 12/14/2018

Alcohol-Related Deaths and Cancer Fatalities Surge in U.S. Over Past Two Decades

Oncology
  • Alcohol-related deaths in the United States nearly doubled from 1999 to 2020, rising from 10.7 to 21.6 per 100,000 people, with women experiencing the largest relative increase despite men having higher overall rates.
  • Cancer deaths linked to alcohol consumption doubled between 1990 and 2021, increasing from approximately 12,000 to over 23,000 annual deaths, with men accounting for 70% of these fatalities.
  • The 25-34 age group experienced a nearly fourfold spike in alcohol-related deaths, while liver cancer emerged as the leading cause of alcohol-related cancer deaths with 7,408 fatalities in 2021.
  • Despite alcohol being classified as a carcinogen since 1987, only 45% of Americans recognize the cancer risk compared to 89% who understand tobacco's link to cancer.

FDA Approves 25 First-Time Generic Drugs in First Half of 2025, Expanding Access to Critical Therapies

FDA ApprovalDrug ApprovalOncology
  • The FDA approved 25 first-time generic drugs in the first six months of 2025, including generics for critical medications treating HIV, cancer, and neurological conditions.
  • Notable approvals include generic versions of Xarelto (rivaroxaban) for blood clot prevention, Complera for HIV treatment, and Fycompa (perampanel) for seizure management.
  • These generic approvals span diverse therapeutic areas from oncology to ophthalmology, potentially reducing healthcare costs while maintaining equivalent clinical benefits to brand-name products.

Porton Advanced Accelerates Development of Innovative Cell Therapies for Solid Tumors with Key Partnerships

CAR-TOncology
  • Porton Advanced's CDMO services have enabled Tasly Pharmaceutical's dual-targeting CAR-T therapy for recurrent glioblastoma to receive IND approval from China's NMPA, demonstrating the effectiveness of their end-to-end manufacturing platform.
  • The company has established a new partnership with Hualong Biological to accelerate the development of Multi-Activated T Cell (MATC) therapy for solid tumors, leveraging Porton's regulatory expertise and manufacturing capabilities.
  • With 18 global IND approvals and specialized platforms for plasmids, viral vectors, and cell therapies, Porton Advanced is positioning itself as a leading CDMO in the advanced therapy medicinal products (ATMPs) sector.

Bayer Secures FDA Approval for Nubeqa in Metastatic Prostate Cancer, Targeting €3 Billion Peak Sales

OncologyDrug Approval
  • Bayer received FDA approval for Nubeqa (darolutamide) in combination with docetaxel chemotherapy for metastatic hormone-sensitive prostate cancer, expanding beyond its initial non-metastatic indication.
  • The ARASENS trial demonstrated a 33% reduction in death risk when Nubeqa was added to standard androgen deprivation therapy plus docetaxel compared to placebo.
  • Bayer has tripled its peak sales forecast for Nubeqa from €1 billion to €3 billion following positive clinical data in the metastatic setting.
  • The approval positions Nubeqa to compete directly with established androgen receptor inhibitors Xtandi and Erleada in the advanced prostate cancer market.

FDA Approves Datopotamab Deruxtecan for Previously Treated EGFR-Mutated NSCLC

Drug ApprovalOncology
  • The FDA granted accelerated approval to datopotamab deruxtecan-dlnk (Dato-DXd; Datroway) for patients with previously treated EGFR-mutated non-small cell lung cancer who have progressed on both EGFR-targeted therapies and chemotherapy.
  • Clinical trials TROPION-Lung05 and TROPION-Lung01 demonstrated a 45% overall response rate and median duration of response of 6.5 months in this patient population.
  • The approval addresses a significant unmet medical need in a treatment setting with limited therapeutic alternatives for patients with advanced EGFR-mutated NSCLC.
  • While the drug requires monitoring for adverse effects including stomatitis and interstitial lung disease, the safety profile is considered manageable by oncologists.

A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer

NCT04191499Active, Not RecruitingPhase 2
Hoffmann-La Roche
Posted 1/29/2020

Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

NCT04484142Active, Not RecruitingPhase 2
Daiichi Sankyo
Posted 3/30/2021

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

NCT04008030Active, Not RecruitingPhase 3
Bristol-Myers Squibb
Posted 8/5/2019

Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

NCT04656652Active, Not RecruitingPhase 3
Daiichi Sankyo
Posted 12/21/2020

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

NCT05257408Active, Not RecruitingPhase 3
Corcept Therapeutics
Posted 6/29/2022

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Imetelstat in Combination With Ruxolitinib in Participants With Myelofibrosis

NCT05371964RecruitingPhase 1
Geron Corporation
Posted 5/4/2022

Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer

NCT03839823CompletedPhase 2
Novartis Pharmaceuticals
Posted 2/25/2019

A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

NCT03462719Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 4/17/2018

Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis

NCT06097832RecruitingPhase 1
Nexcella Inc.
Posted 6/5/2024

Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)

NCT02910583CompletedPhase 2
Pharmacyclics LLC.
Posted 9/28/2016

Systemic Therapy With or Without Local Consolidative Therapy in Treating Patients With Oligometastatic Solid Tumor

NCT03599765Active, Not RecruitingPhase 2
M.D. Anderson Cancer Center
Posted 7/31/2018

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.