Clinical Trial News
Cilta-cel Demonstrates Overall Survival Benefit in Relapsed/Refractory Multiple Myeloma
- Cilta-cel, a CAR T-cell therapy, significantly improved overall survival (OS) compared to standard-of-care regimens in patients with relapsed/refractory multiple myeloma.
- The CARTITUDE-4 trial showed a statistically significant and clinically meaningful OS benefit in lenalidomide-refractory patients who had received 1-3 prior lines of therapy.
- Safety data from the trial were consistent with the established safety profile of cilta-cel, with no new safety signals identified.
- These results support potential label updates and reinforce cilta-cel's role as an effective treatment option in earlier lines of multiple myeloma therapy.
Highlighted Clinical Trials:
Janssen Research & Development, LLC
Posted 6/12/2020
FDA Approves Donanemab (Kisunla) for Early Alzheimer's Disease
- The FDA has approved donanemab (Kisunla) by Eli Lilly, a monoclonal antibody, for treating early symptomatic Alzheimer's disease, marking it as the second drug of its kind.
- Clinical trials demonstrated that Kisunla slowed cognitive and functional decline by up to 35% over 18 months compared to placebo, offering a significant advancement in Alzheimer's treatment.
- Kisunla targets amyloid plaques in the brain, a key indicator of Alzheimer's, and is administered via monthly infusions, with the potential for treatment cessation based on brain scan improvements.
- While Kisunla presents risks like brain swelling or bleeding, the FDA has determined that its benefits outweigh these risks, providing a new option for patients in the early stages of Alzheimer’s.
Highlighted Clinical Trials:
Eli Lilly and Company
Posted 12/18/2017
Global Dementia Clinical Trial Landscape Analyzed in New Report
- A new report analyzes the global landscape of clinical trials for dementia, providing an overview of trial numbers and average enrollment across top countries.
- The report covers clinical trials by region, country (G7 & E7), phase, trial status, endpoint status, and sponsor type, offering a comprehensive view of the research efforts.
- Key companies involved in dementia therapeutics clinical trials are highlighted, along with prominent drugs in ongoing trials, aiding in competitive strategy development.
- The analysis includes unaccomplished trials (terminated, suspended, and withdrawn) with reasons for incompletion, offering insights into trial success rates and potential challenges.
FDA Approves Ahzantive, a Biosimilar to Eylea, for Retinal Diseases
- The FDA has approved Ahzantive (aflibercept-mrbb) as a biosimilar to Eylea for treating retinal diseases.
- Ahzantive is indicated for neovascular age-related macular degeneration, diabetic macular edema, and other retinal conditions.
- Clinical data showed Ahzantive's efficacy, safety, pharmacokinetics, and immunogenicity are comparable to Eylea.
- The approval expands affordable treatment options for retinal diseases, with potential EMA approval expected by early 2025.
Eirion Therapeutics Initiates Phase 1 Trial of ET-02 for Androgenic Alopecia
- Eirion Therapeutics has begun a Phase 1 clinical trial to assess the safety of topical ET-02 for treating androgenic alopecia (age-related hair loss).
- The double-blind, placebo-controlled study will evaluate the safety of once-daily ET-02 treatment over 28 days in approximately 24 participants.
- ET-02 targets hair follicle stem cells, aiming to restore their normal activity and function, potentially offering a more effective treatment than existing options.
- Pre-clinical studies showed ET-02's potential to restore hair growth and normalize hair follicle structure, suggesting it may also prevent androgenic alopecia.
FDA Approves Nypozi (filgrastim-txid) as Biosimilar to Neupogen
- The FDA has approved Nypozi (filgrastim-txid), a biosimilar to Amgen's Neupogen, marking a significant milestone for Tanvex BioPharma, transitioning it into a commercial entity.
- Nypozi is indicated to reduce infection incidence, particularly febrile neutropenia, in non-myeloid malignancy patients undergoing myelosuppressive anticancer treatments.
- Filgrastim products, including Neupogen and biosimilars, generated over $400 million in sales in the U.S. in the 12 months leading up to March 2024.
- Tanvex BioPharma launched Nypozi in Canada in January 2024, expanding its market presence prior to the U.S. FDA approval.
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.
SpringWorks Therapeutics Submits NDA for Mirdametinib in NF1-Associated Plexiform Neurofibromas
- SpringWorks Therapeutics has completed its NDA submission to the FDA for mirdametinib, targeting pediatric and adult patients with NF1-PN.
- The submission is based on Phase 2b ReNeu trial data, showcasing significant objective response rates and improved quality of life.
- Mirdametinib has received Orphan Drug and Fast Track designations from the FDA, and a MAA filing with the EMA is planned for later in 2024.
- NF1-PN affects approximately 30-50% of individuals with NF1, causing tumors along nerve sheaths, leading to disfigurement and functional impairment.
Highlighted Clinical Trials:
SpringWorks Therapeutics, Inc.
Posted 9/29/2019
FDA Approves Pyzchiva (ustekinumab-ttwe), Biosimilar to Stelara, for Inflammatory Conditions
- The FDA has approved Pyzchiva (ustekinumab-ttwe) as a biosimilar to Stelara for treating moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
- Pyzchiva, developed by Samsung Bioepis and commercialized by Sandoz, is expected to launch in the U.S. in February 2025, potentially offering a more affordable treatment option.
- Clinical studies confirmed Pyzchiva's equivalent efficacy and comparable safety to Stelara, supporting its approval for both adult and pediatric patients with approved indications.
- The approval of Pyzchiva aims to increase patient access to biologic treatments and reduce healthcare costs, particularly in the U.S. where biologics constitute a significant portion of drug spending.
AI and Data Analytics Could Reduce Clinical Trial Failure Rates by 20%, QuantHealth CEO Reports
- Over 90% of experimental therapies currently fail in human trials, highlighting a critical need for innovation in clinical trial design and execution.
- QuantHealth's AI-powered platform could potentially reduce clinical trial failure rates by 20% through advanced data analytics and improved trial design.
- Digital transformation of patient data is expected to revolutionize trial recruitment and enable synthetic control arms within the next decade.