SWX:ROG

Genentech Presents New Data Demonstrating the Potential of Glofitamab and Mosunetuzumab as Fixed-Duration, Off-The-Shelf Treatment Options for Lymphoma

Retrieved on: 
Monday, December 12, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology

These data will be presented at the meeting and simultaneously published online in the New England Journal of Medicine (NEJM).

Key Points: 
  • These data will be presented at the meeting and simultaneously published online in the New England Journal of Medicine (NEJM).
  • Additionally, updated data for mosunetuzumab continued to demonstrate clinically meaningful outcomes in people with heavily pretreated follicular lymphoma (FL).
  • New glofitamab and mosunetuzumab data continue to demonstrate durable and impressive patient responses, including complete remissions, when given for a fixed period of time.
  • Simultaneously, an earlier data cut from the Phase II NP30179 study in R/R diffuse large B-cell lymphoma (DLBCL) was published online in NEJM.

Genentech Presents New and Updated Data for Polivy in Previously Untreated Diffuse Large B-Cell Lymphoma at ASH 2022

Retrieved on: 
Sunday, December 11, 2022
Research, Hospitals, Genetics, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Liver, Phase, Pain scale, Society, Rituximab, NHL, B-cell lymphoma, Lymphoma, Patient, ROG, Pharmacokinetics, Risk, DLBCL, Rash, Skin, Prednisone, Doxorubicin, RO, ADC, Death, Fatigue, Muscle weakness, Pain, Abdomen, Vincristine, Quality of life (healthcare), Tumor lysis syndrome, Infection, Dizziness, Confusion, Food, CD79B, Chills, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Cough, Oxaliplatin, Diarrhea, PFS, Overalls, Urination, ASH, Exposition, Arm, Salvage therapy, Nausea, Progression-free survival, Vomiting, Weight loss, Survival, Safety, Hoffmann-La Roche, Walking, Fever, Cyclophosphamide, Fine chemical, Pharmaceutical industry, Medical device, Vaccine, Genentech, Polatuzumab vedotin, EU

Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).

Key Points: 
  • Data from the POLARIX study support the potential benefit of Polivy in combination with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to improve outcomes for people with previously untreated diffuse large B-cell lymphoma (DLBCL).
  • Too many patients with diffuse large B-cell lymphoma see their cancer relapse or progress after initial treatment.
  • These updated POLARIX data indicate the potential benefits that this Polivy based-regimen could bring to people living with this aggressive type of lymphoma, and demonstrate our commitment to developing new treatment options.
  • Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkins lymphoma (NHL), accounting for about one in three cases of NHL.

Interim Data From Phase III Study Presented at ASH 2022 Show Hemlibra (emicizumab-kxwh) Achieved Meaningful Bleed Control in Infants From Birth

Retrieved on: 
Sunday, December 11, 2022
Research, Parenting, Baby, Maternity, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Other Science, Intracranial hemorrhage, Phase, Arm, Leg, Lung, Ixa, Factor, Female, Thrombotic microangiopathy, Haemophilia, Inherited disorders of trafficking, Life, Protein, Skin, APCC, Society, TMA, ABR, Patient, Blood, RO, HAVEN, Parent, Bleeding, AE, Woman, World government, Quality of life, ROG, Caregiver, Clinical trial, VIII, Safety, Brain, Hoffmann-La Roche, Pharmacokinetics, World Federation of Hemophilia, Trauma, AES, ASH, Factor X, Risk, Birth control, Pharmaceutical industry, Emicizumab, Genentech

The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.

Key Points: 
  • The new data were presented at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in New Orleans from December 10-13, 2022.
  • Hemlibra provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • HAVEN 7 is a Phase III, multi-center, open-label study evaluating the efficacy, safety, pharmacokinetics and pharmacodynamics of Hemlibra in infants with severe hemophilia A without factor VIII inhibitors.
  • Genentech also presented data from the European Haemophilia Safety Surveillance (EUHASS) database and the prospective observational ATHN 7 study at ASH 2022.

Genentech to Present Data at ASH 2022 Showcasing Strength of Hematology Portfolio and Expanding Into New Areas to Address More Patient Needs

Retrieved on: 
Thursday, November 3, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Other Health, ROG, Society, DLBCL, Cyclophosphamide, European Medicines Agency, FDA, Population, Adult, European Commission, B-cell lymphoma, Interim, Hematology, Rituximab, Hoffmann-La Roche, Acquisition, Disease, Spark Therapeutics, Phase, 2021 Essex County Council election, Food, Multiple myeloma, ASH, Degenerative disease, VIII, Lymphoma, Prednisone, RO, Muscle, Intracranial hemorrhage, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, PNH, NHL, Polatuzumab vedotin, Joint, Haemophilia, MM, Industry, Safety, Royal commission, Doxorubicin, Therapy, Quality of life (healthcare), Emicizumab, Risk, Lymphatic system, News, AAV, Follicular lymphoma, Pharmaceutical industry, Medical device, Patient, EU, Genentech

The data we are presenting reinforce our ongoing commitment to redefining treatment paradigms, improving on existing standards of care and addressing a diversity of patient and healthcare system needs.

Key Points: 
  • The data we are presenting reinforce our ongoing commitment to redefining treatment paradigms, improving on existing standards of care and addressing a diversity of patient and healthcare system needs.
  • The data at this years meeting exemplify Genentechs commitment to investing in its current portfolio to further improve patient outcomes.
  • Further information on the key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.
  • Follow Genentech on Twitter via @Genentech and LinkedIn and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH22.

Positive Topline Phase III Results Show Genentech’s Vabysmo Improved Vision for People Living With Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, October 27, 2022
Research, FDA, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Optical, Science

Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.

Key Points: 
  • Vabysmo also showed rapid drying of retinal fluid from baseline through week 24, as measured by reduction in central subfield thickness.
  • Detailed results will be presented at an upcoming medical meeting and submitted to regulatory authorities around the world.
  • Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A).
  • Retinal vein occlusion (RVO) is the second most common cause of vision loss due to retinal vascular diseases.

Early Treatment With Genentech’s Ocrevus (ocrelizumab) Leads to Reduced Disease Progression and Healthcare Costs; Nine-Year Safety Data Reinforce Favorable Benefit-Risk Profile

Retrieved on: 
Wednesday, October 26, 2022
Neurology, Biotechnology, Pharmaceutical, General Health, Health, Hospitals, Clinical Trials, Other Health, Hoffmann-La Roche, Congress, Disease, MS, DMT, Multiple sclerosis, RRMS, RO, Family, Pregnancy, Patient, NEDA, HIV disease progression rates, EDSS, MRI, Treatment, PPMS, Disability, ROG, Research, RMS, Safety, ARR, Database, European Committee of the Regions, Pharmaceutical industry, Medical imaging, Genentech

The majority of patients had no relapses (93%), no MRI lesion activity (89%) and no 24-week confirmed disability progression (91%).

Key Points: 
  • The majority of patients had no relapses (93%), no MRI lesion activity (89%) and no 24-week confirmed disability progression (91%).
  • The safety profile of Ocrevus in this trial was consistent with its overall favorable safety profile.
  • Additionally, patients treated with first-line Ocrevus had lower hospitalization rates within one year compared with patients treated with second-line or later Ocrevus (0.02 vs. 0.042, respectively).
  • Tell your healthcare provider if you have had an allergic reaction to Ocrevus or any of its ingredients in the past.

Genentech to Present New Ocrevus (ocrelizumab) Data in Multiple Sclerosis and Continued Research Into Neuromyelitis Optica Spectrum Disorder at ECTRIMS 2022

Retrieved on: 
Wednesday, October 19, 2022
Biotechnology, Pharmaceutical, Health, People, Hoffmann-La Roche, Union, Colon, Birth, Time, Breast milk, Infection, Medicine, Risk, Inflammation, Woman, Vaccine, Patient, IL-6, Recycling, Genentech, Allergy, Hepatitis B, Hepatitis B virus, Immune system, Neutrophil, Disability, Cancer, Health, Antibody, Blood, Breast cancer, Vaccination, Vitamin, Fever, Phase, Colitis, FDA, Pregnancy, Conditional sentence, Breakthrough therapy, Health insurance, Pharmaceutical industry, Birth control, Dietary supplement, Risk management, Liquor, Satralizumab, Ocrelizumab, NMOSD

You should receive any required live or live-attenuated vaccines at least 4 weeks before you start treatment with Ocrevus.

Key Points: 
  • You should receive any required live or live-attenuated vaccines at least 4 weeks before you start treatment with Ocrevus.
  • When possible, you should receive any non-live vaccines at least 2 weeks before you start treatment with Ocrevus.
  • You should use birth control (contraception) during treatment with Ocrevus and for 6 months after your last infusion of Ocrevus.
  • Talk with your healthcare provider about what birth control method is right for you during this time.

Positive New Data for Genentech’s Evrysdi in Largest Trial Ever Undertaken in Patients With Previously-Treated Spinal Muscular Atrophy (SMA)

Retrieved on: 
Wednesday, October 12, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials

Patients had been previously treated with other approved or investigational SMA-targeting therapies, including nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma).

Key Points: 
  • Patients had been previously treated with other approved or investigational SMA-targeting therapies, including nusinersen (Spinraza) or onasemnogene abeparvovec (Zolgensma).
  • Data showed Evrysdi improved or maintained motor function and led to rapid increases in SMN protein levels which were sustained after two years of treatment.
  • Evrysdi is a prescription medicine used to treat spinal muscular atrophy (SMA) in children and adults.
  • If Evrysdi gets in your eyes, rinse your eyes with water
    The most common side effects of Evrysdi include:

Good Therapeutics Announces Acquisition of Conditionally Active PD-1-regulated IL-2 Program by Roche

Retrieved on: 
Wednesday, September 7, 2022
Biotechnology, Pharmaceutical, Health, Technology, CEO, Cancer, Program, Degenerative disease, Therapy, Protein, Achievement, Pain management, RO, Hart–Scott–Rodino Antitrust Improvements Act, Partner, Lists of diseases, Biology, ROG, Acquisition, Patient, Fine chemical, Pharmaceutical industry, Good

With this acquisition, Roche will gain rights to Good Therapeutics innovative, conditionally active, PD-1-regulated IL-2 program and an exclusive right to the platform technology for the development of PD-1-regulated IL-2 receptor agonist therapeutics.

Key Points: 
  • With this acquisition, Roche will gain rights to Good Therapeutics innovative, conditionally active, PD-1-regulated IL-2 program and an exclusive right to the platform technology for the development of PD-1-regulated IL-2 receptor agonist therapeutics.
  • Following the close of the Roche acquisition, the Good Therapeutics team plans to apply the technology for the design of conditionally active therapeutics to other targets in immuno-oncology and beyond in a new company, Bonum Therapeutics.
  • Good Therapeutics was founded to create a new class of conditionally active therapeutics that will be more effective and avoid the problem of systemic immune activation seen with previous versions of such drugs.
  • Good Therapeutics technology is applicable to a wide range of areas including cancer, autoimmune diseases, metabolic disease, and pain management.

FDA Accepts Supplemental Biologics License Application for Genentech's Polivy Combination for People With Previously Untreated Diffuse Large B-Cell Lymphoma

Retrieved on: 
Tuesday, August 16, 2022
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, FDA, Death, Regulation of tobacco by the U.S. Food and Drug Administration, DLBCL, HIV disease progression rates, Risk, Rituximab, Vincristine, Doxorubicin, Hoffmann-La Roche, Patient, RO, PFS, Cyclophosphamide, ROG, Prednisone, Progression-free survival, Food, Pharmaceutical industry, Genentech, Polatuzumab vedotin

Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people.

Key Points: 
  • Although DLBCL often responds to initial treatment, it is not cured with the current standard of care in four out of 10 people.
  • Based on pivotal data from the POLARIX study, the European Commission approved Polivy in combination with R-CHP in May 2022 for the treatment of adult patients with previously untreated DLBCL.
  • POLARIX is being conducted in collaboration with The Lymphoma Study Association (LYSA) and The Lymphoma Academic Research Organisation (LYSARC).
  • Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkins lymphoma (NHL), accounting for about one in three cases of NHL.