Tagged News
Global Breast Cancer Therapeutics Market Expected to Reach $78.61 Billion by 2033
• The global breast cancer therapeutics market, valued at $32.93 billion in 2023, is projected to reach $78.61 billion by 2033, growing at a CAGR of 9.09% over the next decade.
• North America dominates the market with a 38.61% revenue share, driven by high breast cancer prevalence and presence of key pharmaceutical companies including Pfizer, Roche, and Novartis.
• Targeted therapies hold the largest market segment at 64.85%, with hormone receptor-positive treatments accounting for 66.97% of the market as precision medicine approaches gain traction.
Novartis' Ianalumab Advances in Phase 3 Trial for Lupus Nephritis as CDSCO Approves Protocol Amendment
• India's CDSCO expert committee has approved Novartis' protocol amendment for the Phase 3 SIRIUS-LN trial evaluating ianalumab in patients with active lupus nephritis.
• Ianalumab is a novel BAFF-targeting monoclonal antibody that prevents BAFF signaling through its receptor and depletes BAFF-R-expressing B-cells through antibody-dependent cellular cytotoxicity.
• The approval follows Novartis' presentation of protocol amendment version 03 dated December 14, 2023, potentially accelerating the development pathway for this investigational therapy for autoimmune conditions.
Riliprubart Shows Promise as First-in-Class Treatment for Chronic Inflammatory Demyelinating Polyneuropathy
• Sanofi's riliprubart demonstrated significant disease-controlling benefits across all patient cohorts in a Phase 2 study for chronic inflammatory demyelinating polyneuropathy (CIDP), including those who failed standard treatments.
• The complement C1s inhibitor showed sustained efficacy for up to 48 weeks, with 87-92% of participants experiencing improvement or disease stabilization after 24 weeks of treatment.
• Riliprubart reduced neurofilament light chain levels by 35% across all cohorts, suggesting potential reduction in nerve damage, while also improving patient-reported fatigue and quality of life outcomes.
Related Clinical Trials:
NIH's Novel Five-Drug Combination Shows Promise for Relapsed Aggressive B-Cell Lymphoma
• NIH researchers have developed ViPOR, a non-chemotherapy five-drug regimen that achieved complete remission in 38% of patients with relapsed or refractory diffuse large B-cell lymphoma.
• The treatment was particularly effective in two specific subtypes: non-GCB DLBCL (62% complete response) and double-hit GCB DLBCL (53% complete response), offering new hope for patients with limited options.
• At the two-year mark, 36% of all treated patients were still alive and 34% remained disease-free, with some maintaining remission beyond four years despite previously facing poor prognoses.
Outlook Therapeutics Advances ONS-5010 Toward Potential First Approved Ophthalmic Bevacizumab for Retinal Diseases
• Outlook Therapeutics received a positive opinion from the European Medicines Agency's CHMP for ONS-5010/LYTENAVA™ (bevacizumab gamma) for wet AMD treatment, with European Commission decision expected in Q2 2024.
• The company has submitted a Marketing Authorization Application in the UK and is progressing with the NORSE EIGHT clinical trial in the US, with over 30% of subjects enrolled and topline results expected in Q4 2024.
• If approved, ONS-5010 would be the first authorized ophthalmic formulation of bevacizumab for treating retinal diseases, potentially launching in the EU and UK in early 2025 and in the US later that year.
Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands
• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations.
• Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA.
• The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.
FDA to Convene Advisory Committee for Eli Lilly's Alzheimer's Drug Donanemab
• The FDA has announced plans to convene a Peripheral and Central Nervous System Drugs Advisory Committee to review donanemab's efficacy and safety profile before making a final approval decision.
• Donanemab's TRAILBLAZER-ALZ 2 trial employed innovative biomarker strategies, using both Amyvid® and Tauvid™ PET scans to identify early-stage patients with confirmed amyloid plaques most likely to benefit from treatment.
• Experts view anti-amyloid therapies like donanemab as just the first line of defense, with approximately 75% of Alzheimer's drugs in development now exploring novel targets related to aging pathways including inflammation and vascular dysfunction.
Bispecific Antibodies: Promising Advances Amid Adoption Challenges in Cancer Treatment
• Bispecific antibodies represent a significant advancement in cancer immunotherapy, targeting both tumor antigens and immune cells to enhance cytotoxicity without requiring patient-derived cells like CAR-T therapy.
• Despite clinical promise with nine FDA-approved bispecific antibodies, adoption faces challenges including transition between inpatient/outpatient settings, insurance coverage, adverse event management, and financial barriers in community settings.
• Recent approvals of Mosunetuzumab, Glofitamab, and Epcoritamab have shown impressive response rates in relapsed/refractory indolent B-cell lymphomas, with manageable toxicity profiles when using step-up dosing strategies.
Related Clinical Trials:
Abramson Cancer Center at Penn Medicine
Posted 11/5/2021
The Lymphoma Academic Research Organisation
Posted 9/5/2023
Weill Medical College of Cornell University
Posted 11/1/2023
Reid Merryman, MD
Posted 7/18/2023
University of Washington
Posted 3/23/2022
Genmab
Posted 11/3/2020
NCT05529524Completed
The Lymphoma Academic Research Organisation
Posted 11/7/2022
Hoffmann-La Roche
Posted 10/27/2021
FDA Approves Aduhelm: First Disease-Modifying Alzheimer's Treatment in Nearly Two Decades
• The FDA granted accelerated approval to Biogen's aducanumab (Aduhelm) as the first disease-modifying Alzheimer's treatment in nearly two decades, despite divided expert opinions on its clinical efficacy.
• Aduhelm, priced at $56,000 annually, works by reducing amyloid plaques in the brain and will require monthly intravenous infusions with comprehensive clinical and MRI monitoring for potential adverse effects.
• As part of the accelerated approval, Biogen must conduct a Phase 4 confirmatory trial, while experts view this approval as a potential catalyst for developing more effective Alzheimer's treatments targeting multiple pathways.
Related Clinical Trials:
Biogen
Posted 8/13/2015
Biogen
Posted 12/20/2018
Biogen
Posted 9/15/2015
Pertuzumab Regimen Shows Modest Survival Benefit in HER2-Positive Early Breast Cancer
• 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.