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Clinical Trial News

Smoking Poses Heightened Health Risks for HIV Patients, Studies Show

  • Recent studies reveal that people living with HIV who smoke lose more years of life from smoking than from HIV itself, with 50-70% of HIV-positive individuals being smokers.
  • Smoking significantly increases HIV patients' risk of opportunistic infections, cardiovascular disease, and medication complications, with up to 60% higher mortality rates observed in smokers.
  • Public health initiatives like Stoptober and e-cigarette adoption are being promoted as harm reduction strategies, with evidence showing e-cigarettes carry only 5% of tobacco's health risks.

FDA Draft Guidance Clarifies Requirements for Confirmatory Trials Under Accelerated Approval

  • The FDA has issued draft guidance on accelerated approval, focusing on when confirmatory trials must be 'underway'.
  • This guidance interprets 'underway' and details factors the FDA will consider before granting accelerated approval.
  • The guidance aims to ensure timely completion of confirmatory trials, as mandated by the Consolidated Appropriations Act of 2023.
  • Stakeholders can submit comments on the draft guidance until March 10, 2025, for consideration by the FDA.

Fulvestrant Shows Overall Survival Benefit Over Anastrozole in First-Line Advanced Breast Cancer

• A phase II trial (FIRST) comparing fulvestrant 500 mg to anastrozole 1 mg in postmenopausal women with ER-positive advanced breast cancer showed a statistically significant improvement in overall survival (OS). • Patients treated with fulvestrant 500 mg had a median OS of 54.1 months compared to 48.4 months with anastrozole, representing a 30% reduction in mortality risk (HR 0.70, P=0.04). • The OS benefit with fulvestrant was generally consistent across pre-specified subgroups, and no new safety concerns were identified during the follow-up period. • These findings suggest fulvestrant 500 mg could be considered as a first-line treatment option for ER-positive advanced breast cancer, especially where access to other therapies is limited.

A Global Study to Compare the Effects of Fulvestrant and Arimidex in a Subset of Patients With Breast Cancer.

NCT01602380Active, Not RecruitingPhase 3
AstraZeneca
Posted 10/17/2012

A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)

NCT01740427CompletedPhase 3
Pfizer
Posted 2/22/2013

NICE Provisionally Approves BioMarin's Vimizim for Ultra-Rare Morquio Disease with Real-World Data Requirements

• NICE has issued a provisional approval for BioMarin's Vimizim (elosulfase alfa), priced at £395,000 per patient annually, for treating the ultra-rare Morquio disease affecting 88 patients in England.
• The approval is contingent on implementing real-world data collection and establishing a price cap, marking NICE's innovative approach to managing high-cost rare disease treatments.
• The MPS Society welcomes the decision while expressing concerns about further delays in the approval process, as patients urgently await access to this life-changing therapy.

FDA Approves Two New Ustekinumab Biosimilars, Bringing Total US Biosimilar Count to 65

Monoclonal AntibodyDrug Approval
  • The FDA has approved Biocon's Yesintek (ustekinumab-kfce) and Celltrion's Steqeyma (ustekinumab-stba) in November and December 2024, expanding treatment options for autoimmune conditions including Crohn's disease and psoriasis.
  • Of the 65 FDA-approved biosimilars, 14 have received interchangeable designation, allowing pharmacists to substitute them for reference products without prescriber intervention, enhancing patient access to more affordable treatments.
  • The biosimilar landscape continues to evolve with products spanning five major classes: insulin, granulocyte colony-stimulating factors, monoclonal antibodies, TNF-alpha inhibitors, and VEGF inhibitors.

Ropeginterferon Alfa-2b Shows Promise in Polycythemia Vera Treatment

  • Ropeginterferon alfa-2b demonstrates a high overall response rate of 90% in polycythemia vera (PV) patients, including complete and partial hematologic responses.
  • The study found no dose-limiting toxicities with ropeginterferon alfa-2b, supporting its favorable safety profile and potential for long-term use.
  • Treatment with ropeginterferon alfa-2b led to significant reductions in JAK2 V617F allelic burden, indicating molecular responses in PV patients.
  • The research suggests that ropeginterferon alfa-2b could effectively normalize blood cell counts and prevent thromboembolic complications in PV patients.

Safety Study of Pegylated Interferon Alpha 2b to Treat Polycythemia Vera

NCT01193699CompletedPhase 1
AOP Orphan Pharmaceuticals AG
Posted 8/1/2010

Europe Emerges as Leading Hub for Precision Medicine Innovation and Implementation

  • Europe's healthcare systems are rapidly adopting genomic medicine and personalized therapies, driven by collaboration among providers, payers, and pharmaceutical companies across the continent.
  • The convergence of advanced diagnostics, genetic analytics, and companion diagnostics has created a mature ecosystem for precision medicine delivery in everyday clinical practice.
  • European institutions' willingness to share platforms and data while maintaining security standards positions the continent to potentially surpass the US in precision medicine commercialization.

AstraZeneca Expands Immuno-Oncology Portfolio with Three Strategic Partnerships

• AstraZeneca secures rights to Inovio's INO-3112, a DNA vaccine targeting HPV-related cancers, in a deal worth up to $727.5 million, planning combination studies with durvalumab.
• MedImmune partners with Heptares on adenosine A2A receptor antagonist HTL-2071 for $510 million, aiming to enhance T-cell anti-cancer activity.
• A collaboration with Mirati Therapeutics will explore combining durvalumab with HDAC inhibitor mocetinostat in non-small cell lung cancer trials starting next year.

India Revamps Clinical Trial Regulations to Align with Global Standards

  • India has significantly reformed its clinical trial regulations, extending SAE reporting timelines from 10 to 14 days to match international standards and streamlining the approval process.
  • The regulatory framework now requires trials to be evaluated based on risk-benefit assessment, innovation value, and unmet medical needs in the country, ensuring greater transparency.
  • New draft standards for accreditation of sites, investigators, and ethics committees have been introduced by CDSCO, aiming to enhance operational standards across clinical research.

Palbociclib Plus Letrozole Significantly Extends Progression-Free Survival in ER+ Breast Cancer

• Palbociclib, a CDK4/6 inhibitor, combined with letrozole, an aromatase inhibitor, significantly improved progression-free survival (PFS) in postmenopausal women with ER+/HER2- metastatic breast cancer. • The PALOMA-1/TRIO-18 phase II trial demonstrated a median PFS of 20.2 months with the palbociclib-letrozole combination, compared to 10.2 months with letrozole alone. • Palbociclib received accelerated FDA approval based on these results, pending confirmatory phase III trial outcomes, marking a significant advancement in targeted therapy for hormone receptor-positive breast cancer. • Common adverse events associated with the combination therapy included neutropenia and leukopenia, manageable through dose modification and blood count monitoring.

A Study of Abemaciclib (LY2835219) in Participants With Breast Cancer, Non-small Cell Lung Cancer, or Melanoma That Has Spread to the Brain

NCT02308020CompletedPhase 2
Eli Lilly and Company
Posted 4/20/2015

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

NCT01864746CompletedPhase 3
German Breast Group
Posted 10/30/2013

Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)

NCT01976169CompletedPhase 1
University of Texas Southwestern Medical Center
Posted 1/24/2014

PIPA: Combination of PI3 Kinase Inhibitors and PAlbociclib

NCT02389842Unknown StatusPhase 1
Royal Marsden NHS Foundation Trust
Posted 3/25/2015

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

NCT02384239CompletedPhase 2
University of California, San Francisco
Posted 10/19/2015

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135CompletedPhase 3
Pfizer
Posted 9/26/2013

A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer

NCT02296801CompletedPhase 2
NSABP Foundation Inc
Posted 1/1/2015

PD 0332991 and Anastrozole for Stage 2 or 3 Estrogen Receptor Positive and HER2 Negative Breast Cancer

NCT01723774Active, Not RecruitingPhase 2
Washington University School of Medicine
Posted 4/10/2013

Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors

NCT02028507CompletedPhase 3
Spanish Breast Cancer Research Group
Posted 3/13/2014

A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]

NCT02297438Active, Not RecruitingPhase 3
Pfizer
Posted 3/23/2015

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

NCT02040857CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2014

A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer

NCT01684215CompletedPhase 2
Pfizer
Posted 10/19/2012

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