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biologic therapy; biologics

Health

Serplulimab Approved: New Hope for Small Cell Lung Cancer Patients in UK

by Dr. Michael Lee – Health Editor June 24, 2025
written by Dr. Michael Lee – Health Editor

UK Approves First Anti-PD-1 Monoclonal Antibody for Aggressive Lung Cancer – A Breakthrough in Treatment

London, UK – June 24, 2025 – In a landmark decision offering new hope to patients, teh Medicines and Healthcare products Regulatory Agency (MHRA) has approved serplulimab (Hetronifly, Henlius) as a treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) [[1]]. This allows the body’s immune system to more effectively recognize and destroy malignant cells – a significant improvement over traditional chemotherapy alone.

Treatment Protocol

The therapy is administered intravenously every three weeks, in combination with standard chemotherapy drugs carboplatin and etoposide [[1]], [[1]]. Treatment will continue as long as the patient demonstrates clinical benefit.

MHRA statement

“As the first and onyl anti-PD-1 monoclonal antibody approved in the UK for small cell lung cancer, this marks an crucial new treatment option for patients,” stated Julian Beach, interim executive director of healthcare quality and access at the MHRA

June 24, 2025 0 comments
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Health

Datroway’s NSCLC Drug Approved by FDA – Second Green Light

by Dr. Michael Lee – Health Editor June 24, 2025
written by Dr. Michael Lee – Health Editor

FDA Greenlights Datroway for EGFR-Mutated Lung Cancer, Expanding ADC’s Reach

Washington D.C. – June 24, 2025 – In a critically important win for patients battling advanced lung cancer, the food and Drug Governance (FDA) today announced the accelerated approval of datopotamab deruxtecan-dlnk (Datroway), developed by Daiichi Sankyo and AstraZeneca, for the treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer [[1]]. This approval specifically targets individuals who have previously undergone treatment with both EGFR-directed therapies and platinum-based chemotherapy.

Datroway is a trop-2-directed antibody and topoisomerase inhibitor conjugate,representing a cutting-edge approach to cancer treatment. This marks the second approval for this innovative antibody drug conjugate. It initially received approval earlier this year for patients with previously treated unresectable or metastatic HR-positive, HER2-negative breast cancer [[1]].

The decision is based on compelling data from the TROPION-Lung05 and TROPION-Lung01 trials, a pooled subgroup analysis of 114 patients, demonstrating a confirmed overall response rate of 45% and a median duration of response of 6.5 months [[1]], [[1]]. The recommended dosage is 6 mg/kg, capped at 540 mg for patients weighing 90 kg or more, administered intravenously every three weeks until disease progression or unacceptable side effects occur.

Interestingly, AstraZeneca previously withdrew it’s marketing application for Datroway in the EU for non-squamous non-small cell lung cancer, citing feedback from the European Medicines Agency. This decision underscores the rigorous regulatory landscape and the importance of complete clinical data.

What This Means for Patients:

This approval offers a new hope for patients with EGFR-mutated lung cancer who have exhausted other treatment options.Antibody-drug conjugates like Datroway are designed to deliver potent chemotherapy directly to cancer cells, minimizing damage to healthy tissue.Stay tuned to world-today-news.com for ongoing coverage of this developing story and the latest advancements in cancer treatment.

Keywords: FDA, Datroway, datopotamab deruxtecan, lung cancer, non-small cell lung cancer, EGFR, antibody drug conjugate, AstraZeneca, Daiichi Sankyo, cancer treatment, clinical trials, TROPION-Lung05, TROPION-Lung01.

June 24, 2025 0 comments
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Health

Circulating Tumor DNA Guides Lymphoma Treatment Decisions

by Dr. Michael Lee – Health Editor June 23, 2025
written by Dr. Michael Lee – Health Editor

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Potential for Change

The new test could replace the need for invasive gastroscopies in confirming a diagnosis. The strength of the IL-2 signal correlates with symptom severity, potentially allowing doctors to anticipate how a patient might react to gluten without them having to consume it. Currently, about 83% of people with celiac disease remain undiagnosed, according to Beyond Celiac (Source 2024).

Expert Perspective

The new diagnostic approach is seen as welcome, potentially changing practice. Christopher Cao, director of the Celiac Disease Program at Mount Sinai Health System, noted that a gluten challenge can be difficult for patients. The new test could improve the ability to accurately diagnose celiac disease, especially in those already on a gluten-free diet.

Further research will explore the test’s generalizability across diverse patient groups and the role the new assay may play in overall celiac disease testing.

June 17, 2025 0 comments
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Health

EULAR/ERS Guideline: Managing CTD-ILD – New Recommendations

by Dr. Michael Lee – Health Editor June 15, 2025
written by Dr. Michael Lee – Health Editor

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New Guidelines Call for Increased Interstitial Lung Disease Screening in Autoimmune Patients

Table of Contents

  • New Guidelines Call for Increased Interstitial Lung Disease Screening in Autoimmune Patients
    • Screening Recommendations for Interstitial Lung Disease
    • Monitoring ILD Progression After Diagnosis
    • Treatment Strategies for Interstitial Lung Disease

BARCELONA, Spain – In a move set to reshape clinical practice, the European Alliance of Associations for Rheumatology (EULAR) and the European Respiratory Society (ERS) have jointly released new guidelines advocating for systematic screening of interstitial lung disease (ILD) in all patients diagnosed with systemic sclerosis (SSc) and mixed connective tissue disease (MCTD). The declaration was made at the EULAR 2025 Annual Meeting.

These complete, disease-specific recommendations aim to standardize the screening, diagnosis, and management of ILD across various connective tissue diseases (CTDs), including SSc, MCTD, rheumatoid arthritis (RA), idiopathic inflammatory myopathies (IIM), and Sjögren’s disease (SjD).The guidelines mark a notable step forward, representing the first collaborative effort between rheumatologists and pulmonologists in Europe to address ILD in this patient population.

Screening Recommendations for Interstitial Lung Disease

the cornerstone of the new guidelines is the strong recommendation for systematic ILD screening using high-resolution computed tomography (HRCT) in all SSc and MCTD patients, irrespective of pre-existing risk factors. This recommendation extends to patients with IIM, excluding those with inclusion body myositis. For individuals with RA,SjD,and other CTDs,the guidelines advise an initial assessment for disease-specific risk factors,followed by HRCT screening for those with identified risks.

Did You Know? The American Thoracic Society estimates that ILD affects approximately 15% of patients with rheumatoid arthritis[[1].

While previous recommendations supported screening in SSc, the inclusion of RA patients with risk factors marks a significant expansion. According to Dr. Bernhard Hellmich, this broadened scope is expected to identify more patients who could benefit from early therapeutic intervention, potentially leading to improved long-term outcomes.

Notably, the guidelines do not specify a screening frequency due to limited evidence. Dr. Anna-Maria Hoffmann-Vold suggests mirroring the diagnostic approach and reassessing for new ILD progression risk factors. The guidelines explicitly advise against substituting HRCT with pulmonary function tests or lung ultrasound for initial screening. However, forced vital capacity and diffusing capacity of the lungs for carbon monoxide can be incorporated in the presence of symptoms or CT abnormalities.

Monitoring ILD Progression After Diagnosis

The guidelines provide specific timeframes for monitoring ILD progression post-diagnosis, tailored to individual diseases and stratified by ILD progression risk. Clinicians are advised to assess risk based on prior lung function tests, HRCT results, the 6-minute walking test, and risk factors such as disease-specific circulating markers, disease activity, and HRCT patterns.

Based on these assessments, patients are categorized as high or low risk. Monitoring frequency varies accordingly. for high-risk patients with any CTD, lung function tests are recommended every 3-6 months during the initial years, followed by every 6-12 months thereafter. Lower-risk patients should undergo lung function tests every 6-12 months initially, and then annually.

Treatment Strategies for Interstitial Lung Disease

the new guidelines offer detailed treatment recommendations, outlining available options for each disease and providing guidance on selecting the most appropriate medication for individual patients. The guidelines strongly recommend tocilizumab for SSc-ILD patients with early diffuse SSc and signs of inflammation. For IIM-ILD patients, immunosuppressive treatment, including glucocorticoids, calcineurin inhibitors, rituximab, mycophenolate, or azathioprine, is recommended.

Other treatment recommendations are conditional, reflecting limited patient populations and a scarcity of randomized controlled trials. Individual treatment algorithms are provided for SSc-ILD, RA-ILD, and IIM-ILD.

Dr. Hellmich believes that these comprehensive guidelines will facilitate earlier treatment initiation, potentially improving patient prognosis. He noted that the inclusion of certain therapies in the EULAR guidelines may encourage their use in clinical practice,even if they are currently considered off-label.

Pro Tip: Staying informed about the latest research and guidelines is crucial for providing optimal care to patients with connective tissue diseases and interstitial lung disease.

The full guidelines are slated for publication next month in the Annals of the Rheumatic Diseases and European Respiratory Journal.

Key Recommendations

June 15, 2025 0 comments
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