Bleomycin

ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 100% Progression Free Survival at 12 months in Phase 2 Trial of Patients with Early Stage Classical Hodgkin Lymphoma

Retrieved on: 
Monday, December 11, 2023

This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.

Key Points: 
  • This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.
  • The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months.
  • Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0).
  • The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9).

Takeda to Present Data at 65th American Society of Hematology (ASH) Annual Meeting, Demonstrating Continued Commitment to Patients with Hematologic Diseases

Retrieved on: 
Monday, November 27, 2023

Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.
  • Takeda’s latest research focuses on improving treatment options for those living with hematologic diseases.
  • “Our aspiration is to deliver life-transforming medicines for difficult-to-diagnose, rare hematologic diseases with high unmet patient need,” said Björn Mellgård, M.D., Ph.D., vice president and global program lead of Rare Genetics and Hematology at Takeda.
  • “Our continued research aims to improve long-term outcomes for patients suffering from these conditions.

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

Retrieved on: 
Wednesday, October 18, 2023

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.

Galmed Announces Allowance of New Patent for Aramchol for the Treatment of Pulmonary and Dermal Fibrosis

Retrieved on: 
Tuesday, September 26, 2023

The approval of the patent in the US and the rest of the world is pending.

Key Points: 
  • The approval of the patent in the US and the rest of the world is pending.
  • With this latest patent, Galmed is strengthening and extending the patent protection of its lead compound, Aramchol, until November 2037.
  • Previously, Galmed reported results showing significant anti-fibrotic effects of Aramchol in a pre-clinical model of lung fibrosis.
  • Treatment with Aramchol resulted in statistically significant fibrosis improvement in a validated bleomycin model of lung fibrosis (IPF), comparable to Pirfenidone which is the gold standard treatment.

AUA Releases Amendment to the Diagnosis and Treatment of Early-Stage Testicular Cancer Guideline

Retrieved on: 
Thursday, September 14, 2023

BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.

Key Points: 
  • BALTIMORE, Sept. 14, 2023 /PRNewswire/ -- Today the American Urological Association (AUA) released the 2023 clinical practice guideline amendment for the diagnosis and treatment of early-stage testicular cancer.
  • Testicular cancer is the most common solid malignancy in young males and is relatively rare, with outcomes defined by specific cancer and patient-related factors.
  • "Since the last testicular cancer guideline was released, the model for management has substantially changed, making an amendment like this critical to effectively treat and manage testicular cancer."
  • Diagnosis and treatment of early-stage testicular cancer: AUA Guideline amendment 2023.

Phase 3 Trial of ADCETRIS® (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma

Retrieved on: 
Tuesday, June 20, 2023

The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.

Key Points: 
  • The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.
  • 12-month post-treatment safety data were consistent with previously presented HD21 data results at the American Society of Hematology 2022 Annual Meeting.
  • Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Six-Year Overall Survival Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma

Retrieved on: 
Thursday, June 15, 2023

The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.

Key Points: 
  • The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.
  • ADCETRIS was approved for advanced Hodgkin lymphoma in 2018 based on an improvement in progression-free survival in combination with chemotherapy agents AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) in the ECHELON-1 trial.
  • Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them,” said David Epstein, Chief Executive Officer, Seagen.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Seagen Announces ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 98% Overall Response Rate and 93% Complete Response Rate in Patients with Early-Stage Classical Hodgkin Lymphoma (cHL)

Retrieved on: 
Tuesday, June 13, 2023

Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.

Key Points: 
  • Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.
  • The study will be presented on June 17, 2023.
  • Immune-mediated AEs observed to date are consistent with the individual safety profile of nivolumab.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Reviva Pharmaceuticals Announced Preclinical Efficacy Data on Brilaroxazine in IPF at the 2023 American Thoracic Society International Conference and Publication in Medical Research Archives

Retrieved on: 
Thursday, May 25, 2023

CUPERTINO, Calif., May 25, 2023 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), respiratory and metabolic diseases, has presented preclinical data on the novel serotonin-dopamine modulator brilaroxazine in idiopathic pulmonary fibrosis (IPF) at the 2023 American Thoracic Society (ATS) International Conference which took place in Washington, DC, USA, May 19-24, 2023. The Company also announced acceptance of this data for publication in Medical Research Archives. The ATS poster and online publication will be available at revivapharma.com/publications.

Key Points: 
  • The Company also announced acceptance of this data for publication in Medical Research Archives.
  • “This preclinical evaluation in IPF provides proof-of-concept support for the potential of brilaroxazine to treat pulmonary fibrosis and inflammation stemming from underlying dysfunction in serotonin signaling in the lung.
  • Brilaroxazine displays a high affinity and functional activity for the 5-HT2A/2B/7 receptors and moderate affinity for the serotonin transporter.
  • Brilaroxazine demonstrated efficacy with significant improvements in key endpoints in the bleomycin (BLM)-induced rat model of IPF.

VYNE Therapeutics Announces Positive Preclinical Data for Inhaled Formulation of VYN201 in an In Vivo Model of Idiopathic Pulmonary Fibrosis

Retrieved on: 
Wednesday, April 19, 2023

“The data from this well-validated preclinical model of IPF clearly demonstrates VYN201’s potential to deliver a potent anti-inflammatory and anti-fibrotic response,” said David Domzalski, President and Chief Executive Officer of VYNE.

Key Points: 
  • “The data from this well-validated preclinical model of IPF clearly demonstrates VYN201’s potential to deliver a potent anti-inflammatory and anti-fibrotic response,” said David Domzalski, President and Chief Executive Officer of VYNE.
  • In this well-validated preclinical model for IPF, lung fibrosis was induced in mice using a single intratracheal dose of bleomycin.
  • Mean control-adjusted lung fibrosis scores for VYN201 1 mg/ml were 65.8% lower compared to the placebo control group at day 21.
  • Treatment with VYN201 1 mg/ml resulted in a 51.8% mean improvement in functional lung volume compared to animals receiving placebo treatment.