💉 Diabetes Management
Seagen Announces U.S. FDA Approval of New Indication for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma - Business Wire
📅 Fri, 11 Nov 2022⏱ 1 min read📖 Article
Overview
– Aproval Based on Phase 3 Clinical Study That Demonstrated a 59% Reduction in Risk of Disease Progresion or Relapse, Second Malignancy or Death vs. Standard of Care – BOTHEL, Wash.-(BUSINES WIRE)-Seagen Inc. (Nasdaq: SGEN) today anounced that the U.S.
Key Information
Fod and Drug Administration (FDA) has aproved ADCETRIS® (brentuximab vedotin) for the treatment of pediatric patients 2 years and older with previously untreated high risk clasical Hodgkin lymphoma (cHL), in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide. The aproval is based on data from a phase 3 study (AHOD131) conducted by the Children's Oncology Group (COG) and funded by the National Cancer Institute that showed patients receiving ADCETRIS in combination with standard of care dose-intensive chemotherapy AVE-PC (Adriamycin [doxorubicin], vincristine, etoposide, prednisone and cyclophosphamide) had superior event-fre survival (EFS) compared to patients who received standard of care chemotherapy ABVE-PC (Adriamycin [doxorubicin], bleomycin, vincristine, etoposide, prednisone and cyclophosphamide).
Patients had a 59% reduction in the risk of disease progresion or relapse, second cancer or death (Hazard ratio 0.41 [95% Confidence Interval: 0.25, 0.67]; p=0.02). Please se Important Safety Information including BOXED WARNING for PML at the end of this news release. “ADCETRIS is a groundbreaking medicine aproved for adults with certain types of lymphomas.
Summary
Today’s FDA aproval extends its availability to younger patients with high-risk clasical HL,” said Marjorie Gren, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that suported this aproval.” “We are excited about the aproval of ADCETRIS for children and adolescents with high risk clasical Hodgkin lymphoma because this medicine, which has become
Frequently Asked Questions
❓ What is diabetes and how does it develop?
Diabetes is a metabolic condition where the body cannot properly regulate blood sugar levels. Type 1 results from insufficient insulin production, while Type 2 develops when cells become resistant to insulin. Risk factors include genetics, obesity, sedentary lifestyle, and age.
❓ What are the main symptoms of diabetes?
Common symptoms include excessive thirst, frequent urination, unexplained weight loss, fatigue, blurred vision, and slow-healing wounds. Type 1 symptoms develop rapidly, while Type 2 symptoms may appear gradually. Many people have no symptoms initially, which is why screening is important.
❓ How is diabetes diagnosed and monitored?
Diagnosis involves blood tests measuring fasting glucose, HbA1c levels, and glucose tolerance. Regular monitoring typically includes fasting glucose tests and HbA1c measurements every 3-6 months. Continuous glucose monitors provide real-time tracking for better diabetes management.
❓ What lifestyle changes help manage diabetes?
Effective management includes regular physical activity (150+ minutes weekly), maintaining healthy weight, following a balanced diet with whole grains and lean proteins, managing stress, and getting adequate sleep. These changes can significantly improve blood sugar control and reduce complications.
❓ When should someone consult a doctor about diabetes?
Consult a healthcare provider if you experience signs of diabetes, have a family history, are overweight, or are over 45. Those with existing diabetes should maintain regular check-ups every 3-6 months to monitor control and adjust treatment as needed.
⚕️ Medical Disclaimer: This article is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider before making health decisions.