Vinblastine

Withdrawn application: Adcetris, 23/02/2024

Retrieved on: 
Wednesday, April 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

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
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Doxorubicin, Safety, Toxicity, Rollcage Stage II, AVD, Progression-free survival, Progressive multifocal leukoencephalopathy, ADC, Febrile neutropenia, Brentuximab vedotin, Patient, Research and development, PFS, Bleomycin, DOR, PML, Hodgkin lymphoma, PD-1, CHL, Lymphoma, Vinblastine, Dacarbazine, Development, Nivolumab, Survival, Massachusetts General Hospital, ADCETRIS, Immunotherapy, Society, Inc., Hospital, Ima Hogg, Pharmaceutical industry, Vaccine, Medical device, Birth control, Seagen

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).

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
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Survival, Brentuximab vedotin, Christie, TAK, Progression-free survival, CHMP, European Commission, IRF, Committee, Bleomycin, Vinblastine, European Directive on Traditional Herbal Medicinal Products, AVD, Doxorubicin, PFS, EC, University of Manchester, Civil service commission, Hodgkin lymphoma, ADC, CD30, ABVD, Risk, Dacarbazine, University, The Christie NHS Foundation Trust, Committee for Medicinal Products for Human Use, Hatim al-Awni, Overalls, Safety, ADCETRIS, Patient, OS, Lymphoma, Medical device, Medical imaging, Pharmaceutical industry, Takeda, Fellow of the Academy of Medical Sciences

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.

Intensity Therapeutics Receives Orphan Drug Designation for the three key ingredients in INT230-6 for the Treatment of Soft Tissue Sarcoma

Retrieved on: 
Thursday, September 7, 2023
US Foods, Intensity, Vinblastine, Marketing, Survival, STS, Cisplatin, Trial of the century, SHAO, ASCO, Sarcoma, Orphan drug, Johns Hopkins University, Patient, Cancer, FDA, Therapy, Food, Pharmaceutical industry

"The designation of cisplatin, vinblastine and our diffusion enhancer, SHAO for orphan status for STS is quite important," said Lewis H. Bender President and CEO.

Key Points: 
  • "The designation of cisplatin, vinblastine and our diffusion enhancer, SHAO for orphan status for STS is quite important," said Lewis H. Bender President and CEO.
  • An FDA condition to obtain orphan drug designation was for the Company to provide a scientific rationale in its application with sufficient data to establish a medically plausible basis for expecting the drug to be effective in STS.
  • The Company submitted clinical data including immune activation results in sarcoma patients.
  • Data also reported at ASCO showed that INT230-6 when delivered locally led to a systemic immune response in several sarcoma subtypes that are considered to be non-immunogenic cancers.

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
Science, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Other Health, Hodgkin lymphoma, Doxorubicin, Inc., Vincristine, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, Hematology, ABVD, ICML, Procarbazine, Survival, Lymphoma, PET, Cyclophosphamide, Bleomycin, ADCETRIS, CHL, PFS, Teaching hospital, Dexamethasone, FSH, Research and development, Dacarbazine, Prednisone, Development, Etoposide, International Conference on Nuclear Disarmament, Oslo, 2008, Patient, Risk, Progressive multifocal leukoencephalopathy, Fertility, BEACOPP, Peripheral neuropathy, Death, Society, Conference, Pharmaceutical industry, Birth control, Seagen

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
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Brentuximab vedotin, Vinblastine, European Hematology Association, Progression-free survival, ABVD, Survival, American Society of Clinical Oncology, Bleomycin, ADCETRIS, AVD, Patient, Peripheral neuropathy, Death, Society, Disease, Dacarbazine, Pharmaceutical industry

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
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Febrile neutropenia, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, European Hematology Association, ICML, Lymphoma, Survival, Aes, Trae tha Truth, EOT, Bleomycin, Toxicity, ADCETRIS, CHL, PFS, Diabetic neuropathy, Research and development, Dacarbazine, Congress, Development, Hair, International Conference on Population and Development, MD, Patient, Risk, Progressive multifocal leukoencephalopathy, BEACOPP, CR, Nausea, Hospital, PD-1, Massachusetts General Hospital, Death, Conference, ORR, Safety, Fatigue, Nivolumab, Pharmaceutical industry, Vaccine, Birth control, Part, Seagen

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.

Intensity Therapeutics' INT230-6 Prolongs Survival Alone or in Combination With Ipilimumab in Adult Patients with Relapsed, Refractory, Metastatic Sarcomas

Retrieved on: 
Saturday, June 3, 2023
Neoplasm, Intensity, Response evaluation criteria in solid tumors, DCR, Survival, Clinical trial, RECIST, Cancer, Royal Marsden Hospital, SHAO, ASCO, Sarcoma, Publication, American Society of Clinical Oncology, Johns Hopkins University, The Royal Marsden NHS Foundation Trust, Patient, TTB, Ipilimumab, Subbiah, Tumor necrosis factor, Scientific Reports, IPI, BMS, Cisplatin, MOS, Pharmacology, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Society, SD, Food, Pharmaceutical industry, Vinblastine

WESTPORT, Conn., June 3, 2023 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral (IT) cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that data from its ongoing phase 1/2 clinical trial demonstrating the efficacy and tolerability of INT230-6, either as monotherapy or in combination with ipilimumab in patients with relapsed, refractory and metastatic sarcomas, will be presented this afternoon at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting being held in Chicago and virtually from June 2-6, 2023.

Key Points: 
  • Abstract Title: Intratumoral INT230-6 (Cisplatin, Vinblastine, SHAO) alone or with ipilimumab (IPI) prolonged survival with favorable safety in adults with refractory sarcomas [Intensity IT-01; BMS#CA184-592].
  • Sarcoma remains a very challenging cancer to treat and has historically proven resistant to checkpoint blockade.
  • Novel approaches are needed for this patient population, and Intensity's data indicate that sarcoma is an attractive target for intratumoral injection.
  • For the combination arm, one subject had yet to reach the first timepoint for SD at the time of data cut-off.

Intensity Therapeutics' Reports Up to 100% Tumor Necrosis After One Dose of Lead Asset, INT230-6 in Phase 2 INVINCIBLE Neoadjuvant Breast Cancer Study at the San Antonio Breast Cancer Symposium (SABCS)

Retrieved on: 
Thursday, December 8, 2022
Therapy, Malignancy, Breast cancer, Vinblastine, National Cancer Institute, Injection, Ipilimumab, Neoplasm, NCT, Intensity, Woman, Data analysis, CD4, Mastectomy, Cooperative research and development agreement, Necrosis, Risk, Development, Bristol Myers Squibb, The Ottawa Hospital, Oncology nursing, Pain, Cisplatin, Ottawa Hospital Research Institute, Clinical trial, Merck & Co., University, T helper cell, Immunosuppression, Pembrolizumab, NCI, Diffusion, NK, Merck Sharp & Dohme Federal Credit Union, Diagnosis, OHRI, Cancer, Annual general meeting, Merck, Breast, Tumor necrosis factor, Immune system, Surgeon, Ontario Institute for Cancer Research, Poster, Patient, SHAO, CRADA, Medicine, Cell death, WOO, Publication, Pharmaceutical industry, Medical imaging, Vaccine

WESTPORT, Conn., Dec. 8, 2022 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company focused on the discovery and development of proprietary, first-in-class immune-based cancer therapies designed to kill tumors and increase immune system recognition of cancers, today presented new data from the INVINCIBLE study in a live Spotlight Session Poster Presentation at the San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held at the Henry B. Gonzalez Convention Center, San Antonio, TX, from December 6-10, 2022.

Key Points: 
  • INT230-6 demonstrated the ability to cause up to 100% necrosis of presurgical breast cancer tumors in the window period from diagnosis to surgery.
  • Adverse events were mostly grade 1 with expected pain at the breast injection site; there were very few systemic adverse effects.
  • There is a waiting period prior to surgery that can last for several weeks, which is a stressful time.
  • The technology uses a dispersion enhancer that can cause high levels of tumor cell death and necrosis in multiple breast cancer subtypes.

United States Vinca Alkaloid Compounds Market Research Report 2022: Vinblastine, Vincristine, and Vindesine - Forecast to 2027 & Cumulative Impact of COVID-19 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, June 28, 2022
Health, Pharmaceutical, Acquisition, Decision-making, USD, Strategic management, Market share analysis, Value, Business Growth Fund, COVID-19, Customer support, Growth, The Wiggles Pty Ltd, CAGR, Use, Compound annual growth rate, State, Consumer, Retail, Vinblastine, Vindesine, Vincristine

The "Vinca Alkaloid Compounds Market Research Report by Product (Vinblastine, Vincristine, and Vindesine), End User, State - United States Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Vinca Alkaloid Compounds Market Research Report by Product (Vinblastine, Vincristine, and Vindesine), End User, State - United States Forecast to 2027 - Cumulative Impact of COVID-19" report has been added to ResearchAndMarkets.com's offering.
  • The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.
  • The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market.
  • It provides the idea of its revenue generation into the overall market compared to other vendors in the space.