MedPath

Tagged News

Rakuten Medical Acquires Critical IRDye 700DX Assets from LI-COR to Secure Photoimmunotherapy Supply Chain

Drug ApprovalOncology
  • Rakuten Medical acquired phthalocyanine dyes including IRDye 700DX from LI-COR Biosciences to ensure consistent supply for its Illuminox cancer therapy platform.
  • The acquisition supports ongoing ASP-1929 clinical trials across multiple oncology indications and strengthens the company's photoimmunotherapy development capabilities.
  • ASP-1929 has already received conditional marketing approval in Japan for head and neck cancer and is currently being studied in a global Phase 3 trial.
  • The strategic move follows recent clinical milestones including first patient enrollment in a Phase 1b/2 combination trial with anti-PD1 therapy at MD Anderson Cancer Center.

An Open-label Study Using ASP-1929 Photoimmunotherapy in Combination With Anti-PD1 Therapy in EGFR Expressing Advanced Solid Tumors

NCT04305795Active, Not RecruitingPhase 1
Rakuten Medical, Inc.
Posted 12/21/2020

Prestige Biopharma Partners with Teva Israel for Trastuzumab Biosimilar Commercialization

Monoclonal AntibodyOncology
  • Prestige Biopharma has entered an exclusive commercialization agreement with Teva Israel for its trastuzumab biosimilar Tuznue (HD201) targeting HER2-positive breast cancer and gastric adenocarcinoma.
  • Phase 3 TROIKA trial data demonstrated equivalent efficacy to Herceptin with 46.6% complete response rate in the biosimilar arm versus 46.2% for the reference product.
  • The European Medicines Agency is currently reviewing the marketing authorization application for Tuznue based on positive clinical trial results.
  • This partnership expands Prestige's global commercialization strategy, following previous agreements with Pharmapark for Russia and Mundipharma for multiple European markets.

FDA Approves Monjuvi in Combination with Lenalidomide for Relapsed/Refractory DLBCL

Drug ApprovalMonoclonal AntibodyOncology
  • The FDA has approved Monjuvi (tafasitamab-cxix) in combination with lenalidomide as the first second-line treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplant.
  • The approval was based on the Phase 2 L-MIND study, which demonstrated a 55% overall response rate with a 37% complete response rate and median duration of response of 21.7 months.
  • Approximately 10,000 patients are diagnosed annually in the United States with relapsed or refractory DLBCL who are not eligible for stem cell transplant, representing a significant unmet medical need.
  • Monjuvi is a humanized CD19-targeting monoclonal antibody that received accelerated approval and will be co-commercialized by MorphoSys and Incyte in the United States.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer

Monoclonal AntibodyOncologyDrug ApprovalTargeted Therapy
• The APHINITY trial's 6-year analysis reveals that adjuvant pertuzumab with trastuzumab plus chemotherapy improved overall survival by 0.9% in HER2-positive early breast cancer patients, though not reaching statistical significance.
• Patients with node-positive disease showed the most significant benefit from the pertuzumab regimen, with a 4.5% absolute improvement in invasive disease-free survival at 6 years compared to placebo.
• The pertuzumab combination maintained a favorable cardiac safety profile with severe cardiac events occurring in less than 1% of patients, supporting its continued use in high-risk HER2-positive early breast cancer.

BioNTech's Cancer Drug Trastuzumab Pamirtecan Meets Primary Endpoint in Phase 3 Breast Cancer Trial

Oncology
  • BioNTech and Duality Biologics announced their antibody-drug conjugate trastuzumab pamirtecan met its primary endpoint of progression-free survival in a phase 3 trial for unresectable or metastatic breast cancer.
  • The head-to-head study compared the experimental ADC treatment against trastuzumab emtansine in patients who had previously received chemotherapy.
  • This marks BioNTech's first late-stage oncology drug to achieve its primary endpoint in a phase 3 study, with plans to file for regulatory approval in China, the EU, and the United States.
  • The positive results drove BioNTech's stock up 10% as investors recognized the potential in a large addressable market with over 350,000 new breast cancer cases annually in China alone.

FDA Approves Henlius-Organon Denosumab Biosimilars BILDYOS and BILPREVDA for Bone Health Conditions

Drug ApprovalMonoclonal AntibodyOncology
  • The FDA has approved BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), biosimilars to PROLIA and XGEVA respectively, developed by Shanghai Henlius Biotech and commercialized by Organon.
  • BILDYOS is indicated for multiple osteoporosis conditions including postmenopausal women at high fracture risk, while BILPREVDA targets cancer-related bone complications and giant cell tumor of bone.
  • The approvals are based on comprehensive data demonstrating the biosimilars are highly similar to reference products with no clinically meaningful differences in safety, purity, and potency.
  • This milestone expands Organon's biosimilars portfolio and represents Henlius's continued success in bringing self-developed biosimilars to the US market.

Landmark TAILORx Trial Shows 70% of Early-Stage Breast Cancer Patients Can Safely Skip Chemotherapy

Precision MedicineOncology
• The TAILORx trial, involving over 10,000 women, demonstrates that approximately 70% of patients with hormone-receptor positive, HER2-negative early breast cancer can safely avoid chemotherapy when guided by genetic testing. • Women over 50 with Oncotype DX recurrence scores of 0-25 showed no significant survival benefit from adding chemotherapy to hormone therapy alone. • The findings could spare an estimated 65,000 women annually in the US from chemotherapy's toxic side effects while maintaining excellent long-term outcomes. • This precision medicine approach represents the largest breast cancer trial to date and marks a paradigm shift toward personalized treatment strategies.

Novartis's Kymriah: Breakthrough CAR-T Therapy Priced at $475,000 Sparks Value Debate

CAR-TDrug ApprovalOncology
  • Novartis's Kymriah, the first FDA-approved CAR-T cell therapy for pediatric acute lymphoblastic leukemia, demonstrates an impressive 83% remission rate in patients who failed traditional treatments.
  • The therapy's $475,000 price tag has ignited debate among healthcare experts, with some defending it as comparable to bone marrow transplants while others argue it's excessive despite its breakthrough status.
  • Novartis has implemented innovative value-based pricing models, including outcome-based contracts where payment is contingent upon patient response and indication-specific pricing for future approvals.

D3Bio's Novel KRAS-G12C Inhibitor Shows Promising Results in Phase 1 Cancer Trial

OncologyPrecision MedicineTargeted Therapy
  • A multinational study led by Chinese University researchers found that D3S-001, a mainland-developed KRAS-G12C inhibitor, demonstrated significant efficacy with over 70% of patients experiencing tumor shrinkage or disappearance.
  • The novel compound from D3Bio inhibits KRAS-G12C mutations at a faster rate and potentially longer duration than existing treatments, according to Dr. Herbert Loong from CUHK's Department of Clinical Oncology.
  • Researchers are planning phase 3 trials with the goal of positioning D3S-001 as a first-line treatment option for patients with KRAS-G12C-driven cancers of the lung, pancreas, and colon.

MedPath

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

© 2025 MedPath, Inc. All rights reserved.