Progressive multifocal leukoencephalopathy

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
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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).

Discovery of Genetic Link to PML Honored by Largest MS Conference in the World

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Tuesday, October 17, 2023
Emerald, Dimethyl fumarate, DRS, Best, FAERS, Great America Committee, Cladribine, MS, Research, JC, Abstract, Brain, Biogen, Breast cancer, COVID, Multiple myeloma, Treatment, Daratumumab, Risk, CLIA, Natalizumab, Multiple sclerosis, Discovery, Belimumab, Death, Health, PML, Disease, American Neurological Association, Rheumatoid arthritis, FDA, Database, Gene, Human polyomavirus 2, BRCA, Bone marrow, Black box, Inflammatory bowel disease, Infection, PPV, Ibrutinib, Rituximab, Lupus, Progressive multifocal leukoencephalopathy, HIV/AIDS, Patient, Pharmaceutical industry

NEWPORT BEACH, Calif., Oct. 17, 2023 /PRNewswire/ -- The discovery of rare genomic variants leading to cases of drug-induced PML shared Best of MSMilan2023 honors for the latest and most breakthrough results at the 9th Joint ECTRIMS-ACTRIMS Meeting.

Key Points: 
  • Two of the variants have a Positive Predictive Value of 100%, the strongest possible indication they are causative.
  • Progressive Multifocal Leukoencephalopathy (PML) is a rare but frequently fatal serious infection of the brain by the JC virus.
  • Out of 1,500 abstracts presented, Dr. Hatchwell's was one of eight highlighted as Best of MSMilan2023 in its content area.
  • Many MS medications currently carry a PML warning, including Tysabri, Ocrevus, and Rituxan, as well as Briumvi, Gilenya, Kesimpta, Mavenclad, Mayzent, Ponvory, and Tecfidera.

Viridian Appoints Sarah Gheuens, M.D., Ph.D., to its Board of Directors

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Monday, September 25, 2023
Health, General Health, Research, Science, Optical, Biotechnology, University of Antwerp, Thalassemia, University, Doctor of Philosophy, HIV, Free University of Brussels (1834–1969), Medicine, Biogen, Beth Israel Deaconess Medical Center, CMO, Teaching hospital, Harvard Medical School, Graves' ophthalmopathy, VUB, Patient, Progressive multifocal leukoencephalopathy, Sickle cell disease, R, Therapy, Free University, Safety, TED, Pharmaceutical industry, Viridian

Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced the appointment of Sarah Gheuens, M.D., Ph.D., to its Board of Directors.

Key Points: 
  • Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases, today announced the appointment of Sarah Gheuens, M.D., Ph.D., to its Board of Directors.
  • During her time at Agios, she has overseen early- and late-stage clinical development globally across multiple indications, including pyruvate kinase deficiency, thalassemia, and sickle cell disease.
  • “I’ve dedicated much of my career to developing medicines for underserved patient populations across a range of therapeutic areas.
  • She also holds a Ph.D. in Medical Sciences from the University of Antwerp, Belgium, and a Master’s in Medical Sciences from Harvard Medical School.

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.

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)

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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.

Leading MS/PML Experts Recommend Genetic Testing to Prevent Fatal Brain Infection

Retrieved on: 
Thursday, March 16, 2023
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NEWPORT BEACH, Calif., March 16, 2023 /PRNewswire/ -- In an editorial in the journal Frontiers in Neurology, two leading multiple sclerosis (MS) experts are advocating for genetic testing to identify MS patients who are at higher risk of developing a devastating side effect from their medications. 

Key Points: 
  • People with MS are faced with the excruciating decision of whether they should take medications that are effective in slowing the progression of the disease, but may also trigger this potentially fatal complication, a rare brain infection called progressive multifocal leukoencephalopathy (PML).
  • The widespread use of such testing could potentially allow the physician to use alternative therapies that do not carry the same risk of PML."
  • PML is caused by the JC virus, which is very common but remains dormant in the vast majority of carriers.
  • And in 2022 alone, there were nearly 600 cases in the FDA's adverse event reporting system.

Research links gene variants to medication-induced fatal brain infection

Retrieved on: 
Wednesday, December 14, 2022
Emerald, Frontiers, Standard of care, Boxed warning, American Academy of Neurology, JC, Rheumatoid arthritis, Sclerosis, American Academy, Genetics, Parkinson's disease, Patient, BRCA, Research, JCV, MS, Precision medicine, Alzheimer's disease, Perelman School of Medicine at the University of Pennsylvania, Breast cancer, Pediatrics, FDA, Black box, Lymphatic system, Human polyomavirus 2, PML, University, Natalizumab, Crohn's disease, Brain, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Risk, Vaccine, Health insurance, Dietary supplement, Pharmaceutical industry, Autism, Endometriosis, Neurology, Medicine

NEWPORT BEACH, Calif., Dec. 14, 2022 /PRNewswire/ --New research has confirmed a strong link between four genetic mutations and progressive multifocal leukoencephalopathy (PML), a rare but often fatal brain infection that can be triggered by dozens of FDA-approved drugs.

Key Points: 
  • NEWPORT BEACH, Calif., Dec. 14, 2022 /PRNewswire/ --New research has confirmed a strong link between four genetic mutations and progressive multifocal leukoencephalopathy (PML), a rare but often fatal brain infection that can be triggered by dozens of FDA-approved drugs.
  • The research will allow doctors to screen out patients with the highest risk of PML.
  • The research, published in Frontiers in Neurology onDecember 14, will allow doctors to screen out patients with the highest risk of PML.
  • The study found that in people taking PML-inducing drugs, having one of four genetic variants increased the risk of PML 8.7 times on average.

Research links gene variants to medication-induced fatal brain infection

Retrieved on: 
Monday, December 12, 2022
Emerald, Frontiers, Standard of care, Boxed warning, American Academy of Neurology, JC, Rheumatoid arthritis, Sclerosis, American Academy, Genetics, Parkinson's disease, Patient, BRCA, Research, JCV, MS, Precision medicine, Alzheimer's disease, Perelman School of Medicine at the University of Pennsylvania, Breast cancer, Pediatrics, FDA, Black box, Lymphatic system, Human polyomavirus 2, PML, University, Natalizumab, Crohn's disease, Brain, Progressive multifocal leukoencephalopathy, Multiple sclerosis, Risk, Vaccine, Health insurance, Dietary supplement, Pharmaceutical industry, Autism, Endometriosis, Neurology, Medicine

NEWPORT BEACH, Calif., Dec. 12, 2022 /PRNewswire/ -- New research has confirmed a strong link between four genetic mutations and progressive multifocal leukoencephalopathy (PML), a rare but often fatal brain infection that can be triggered by dozens of FDA-approved drugs.

Key Points: 
  • NEWPORT BEACH, Calif., Dec. 12, 2022 /PRNewswire/ -- New research has confirmed a strong link between four genetic mutations and progressive multifocal leukoencephalopathy (PML), a rare but often fatal brain infection that can be triggered by dozens of FDA-approved drugs.
  • The research will allow doctors to screen out patients with the highest risk of PML.
  • The research, published in Frontiers in Neurology onDecember 14, will allow doctors to screen out patients with the highest risk of PML.
  • The study found that in people taking PML-inducing drugs, having one of four genetic variants increased the risk of PML 8.7 times on average.

Cellevolve Bio Receives FDA Clearance of IND Application and Orphan Drug Designation for CE-VST01-JC for the Treatment of Progressive Multifocal Leukoencephalopathy (PML)

Retrieved on: 
Tuesday, October 25, 2022
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CE-VST01-JC also received FDA orphan drug designation.

Key Points: 
  • CE-VST01-JC also received FDA orphan drug designation.
  • "We are thrilled to have received IND clearance to begin our Phase 2 clinical study," said Derrell Porter, M.D., Founder and CEO, Cellevolve.
  • PML is a demyelinating disease of the central nervous system (CNS) caused by JCV and occurs in immunocompromised patients.
  • There are no FDA or EMA approved treatments for this condition, which affects ~ 4,000 individuals in the US and Europe annually.

GoodRx and Biogen Collaborate to Help Enhance Enrollment Experience for Providers Who Have Chosen to Start Multiple Sclerosis Patients on VUMERITY®

Retrieved on: 
Thursday, October 13, 2022
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HCPs who have decided to start patients with relapsing forms of multiple sclerosis (MS) on VUMERITY (diroximel fumarate) may now find the enrollment form and submit to the specialty hub through Provider Mode .

Key Points: 
  • HCPs who have decided to start patients with relapsing forms of multiple sclerosis (MS) on VUMERITY (diroximel fumarate) may now find the enrollment form and submit to the specialty hub through Provider Mode .
  • Announced today, GoodRxs Provider Mode is a new experience built specifically for HCPs to help them access solutions for the medications they prescribe.
  • We are proud to work with medical professionals to help patients with relapsing MS get the therapy they need more efficiently.
  • This exciting integration with Biogen is just the start of the great work to come as we expand our offerings for providers.