SWX:ROG

FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

Retrieved on: 
Thursday, April 18, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Phase, Cancer, Anaplastic lymphoma kinase, Risk, Food, ROG, Death, Recurrence, Roche, Disease, Patient, Neoplasm, Biomarker, ALK, NSCLC, Alectinib, Lung cancer, Pharmaceutical industry

Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.

Key Points: 
  • Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.
  • “At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread.
  • In an exploratory analysis, an improvement of central nervous system (CNS)-disease-free survival (DFS) was observed (HR=0.22; 95% CI: 0.08-0.58).
  • Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC.

Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS

Retrieved on: 
Wednesday, April 17, 2024
Health, FDA, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Pain, American Academy, Phase, ARR, OCR, News, Blood, Swelling, Food, ROG, American Academy of Neurology, Erythema, Inflammation, Roche, Disease, Patient, RMS, Neurology, AAN, EMA, Itch, MRI, PPMS, Irritation, Annual general meeting, Food and Drug Administration, European Medicines Agency, Disability, Pharmaceutical industry

Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.

Key Points: 
  • Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.
  • “Updated results from OCARINA II further underline the potential benefits of subcutaneous Ocrevus for patients with both relapsing and progressive forms of MS,” said Scott Newsome, D.O., lead author, Johns Hopkins University School of Medicine.
  • “Patients treated with subcutaneous Ocrevus experienced appropriate B-cell suppression and impressive near-complete suppression of new inflammatory disease activity.
  • There are more than 30 ongoing Ocrevus clinical trials designed to help us better understand MS and its progression.

Genentech’s Columvi Meets Primary Endpoint of Overall Survival in People With Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Study

Retrieved on: 
Monday, April 15, 2024
Research, FDA, Genetics, Clinical Trials, Stem Cells, Biotechnology, Pharmaceutical, Health, Science, Oncology, Phase, Safety, DLBCL, Risk, Food, European Commission, ROG, Survival, Oxaliplatin, Roche, Aggressive lymphoma, Disease, Rituximab, Patient, Civil service commission, GemOx, Diagnosis, B-cell lymphoma, Pharmaceutical industry

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival.

Key Points: 
  • Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today the Phase III STARGLO study met its primary endpoint of overall survival.
  • Safety of the combination appeared consistent with the known safety profiles of the individual medicines.
  • The data will be submitted to health authorities and shared at an upcoming medical meeting.
  • Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, so patients can start treatment soon after diagnosis.

New England Journal of Medicine Publishes Phase III Data Showing Xolair Significantly Reduced Allergic Reactions Across Multiple Foods in People With Food Allergies

Retrieved on: 
Sunday, February 25, 2024
Teens, Women, Children, Men, Clinical Trials, Biotechnology, Health, Consumer, Pharmaceutical, Bangladesh Technical Education Board, AAAAI, Johns Hopkins Children's Center, Research, Food allergy, Hazelnut, NIH, FDA, Food, Immunoglobulin E, Rheumatology, NEJM, Risk, Annual general meeting, Safety, Roche, Milk, ROG, Fear, Patient, Medicine, Asthma, Face, American Academy, Pharmaceutical industry

Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.

Key Points: 
  • Safety findings were consistent with the known safety profile of Xolair across its approved indications and in previous clinical trials.
  • The U.S. Food and Drug Administration (FDA) recently approved the expanded use of Xolair in children and adults with IgE-mediated food allergies based on the OUtMATCH data.
  • “While allergic reactions to exposures are common and often severe, there have been limited treatment advancements for food allergy.
  • “The OUtMATCH study demonstrated that anti-IgE therapy increased most patients’ threshold for an allergic reaction.

FDA Approves Xolair as First and Only Medicine for Children and Adults With One or More Food Allergies

Retrieved on: 
Friday, February 16, 2024
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Infection, Allergy, Bangladesh Technical Education Board, AAAAI, Johns Hopkins Children's Center, Emergency, Hazelnut, NIAID, American Academy, Omalizumab, NIH, Friends, Food, Immunoglobulin E, News, Asthma, Anaphylaxis, FARE, Annual general meeting, Prevalence, Roche, Milk, ROG, AAFA, Patient, Family, Phase, Ageing, Education

People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).

Key Points: 
  • People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”).
  • Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterized by the rapid onset of symptoms following exposure to certain food allergens.
  • Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies.
  • About 3.4 million children and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies, based on estimates for 2024.

New Long-Term Data for Genentech’s Vabysmo Show Sustained Retinal Drying and Vision Improvements in Retinal Vein Occlusion (RVO)

Retrieved on: 
Thursday, February 1, 2024
Biotechnology, Health, Pharmaceutical, Optical, Clinical Trials, Paratriathlon, Inflammation, Ranibizumab, Research, Ophthalmology, RVO, Patient, Diabetic retinopathy, Swelling, CRVO, BRVO, Food, ROG, Bascom Palmer Eye Institute, Retina, Blood, Macular edema, Angiogenesis, Roche, Eye, CST, Telescopic sight

In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.

Key Points: 
  • In addition, patients in the studies maintained vision gains and robust retinal drying achieved in the first 24 weeks of the studies for more than one year.
  • Retinal drying is an important clinical measure as swelling from excess fluid in the back of the eye has been associated with distorted and blurred vision.
  • In both studies, Vabysmo was well tolerated and the safety profile was consistent with previous studies.
  • “The sustained vision improvements and retinal drying seen up to 72 weeks reaffirm Vabysmo as an effective treatment for retinal vein occlusion,” said Ramin Tadayoni, M.D., Ph.D., head of ophthalmology at Université Paris Cité in Paris and president of EURETINA, who is presenting the data at Angiogenesis.

FDA Grants Priority Review to Xolair (omalizumab) for Children and Adults With Food Allergies Based on Positive National Institutes of Health Phase III Study Results

Retrieved on: 
Tuesday, December 19, 2023
Men, Research, General Health, Pharmaceutical, Consumer, Parenting, Clinical Trials, Science, Children, Biotechnology, Women, FDA, Health, Phase, DSMB, Roche, Food, Anaphylaxis, Priority review, Infection, NIAID, Novartis, Allergy, Food allergy, Milk, Prevalence, Ageing, Swelling, ROG, Peanut, Bangladesh Technical Education Board, CSU, Polyp (medicine), NIH, Patient, Asthma, Data monitoring committee, Sinusitis, Pharmaceutical industry

If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”).

Key Points: 
  • If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”).
  • The filing acceptance is based on positive interim analysis results from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods.
  • If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure.
  • “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study.

New Data for Genentech’s Columvi and Lunsumio Presented at ASH 2023 Support Continued Benefit for People With Lymphoma

Retrieved on: 
Monday, December 11, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Doxorubicin, Safety, Lenalidomide, Progression-free survival, Bone marrow, ASH, CRS, Disease, DLBCL, Prednisone, B-cell lymphoma, Rituximab, Patient, Roche, PFS, ROG, Follicular lymphoma, Phases of clinical research, Polatuzumab vedotin, Exposition, Vincristine, GemOx, Cyclophosphamide, Society, OS, Cytokine release syndrome, HIV disease progression rates, Lymphoma, Fine chemical, Pharmaceutical industry, Medical device, Mosunetuzumab, Genentech, Phase, Nature Medicine

Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).

Key Points: 
  • Additionally, new early-phase data of novel Columvi or Lunsumio combination regimens support ongoing investigation in Phase III studies in earlier lines of diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
  • After a median follow-up of 32 months, 55% of patients with a complete response (CR) were in remission at 24 months.
  • Data showed that 83.3% of patients achieved a complete metabolic response (95% CI: 62.6-95.3), and responses were ongoing at data cut-off.
  • The data support further investigation of this SC formulation of Lunsumio and highlight its potential as a tailored monotherapy or combination outpatient therapy for FL, including in community practices.

New Data Reinforce the Benefit of Early Preventative Treatment With Genentech’s Hemlibra (emicizumab-kxwh) for Babies With Severe hemophilia A

Retrieved on: 
Saturday, December 9, 2023
Research, Infectious Diseases, Baby, Maternity, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Consumer, Health, Science, Safety, Haemophilia, Pediatrics, Pathology, ASH, University, Risk, World Federation of Hemophilia, HAVEN, Roche, World government, Death, ROG, Pharmacokinetics, Caregiver, Trauma, Phase, Intraparenchymal hemorrhage, Biomarker, Parent, Society, Vein, Life, Intracranial hemorrhage, Pharmaceutical industry, Birth control, Emicizumab, Genentech

Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.

Key Points: 
  • Results showed that Hemlibra achieved meaningful bleed control in babies up to 12 months of age and was well tolerated.
  • However, for many babies with hemophilia A, prophylaxis is not started until after the first year of life because of the high treatment burden.
  • Hemlibra, which is already approved and being used to treat babies with hemophilia A, provides a flexible treatment option that can be administered subcutaneously from birth at different dosing frequencies.
  • It is approved for the routine prophylaxis of people with hemophilia A in more than 115 countries worldwide.

Genentech’s Inavolisib Combination Reduces the Risk of Disease Progression by 57% in People With Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer With a PIK3CA Mutation

Retrieved on: 
Friday, December 8, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, ROG, Risk, Fulvestrant, Roche, PFS, Progression-free survival, Death, Phase, Fine chemical, Birth control, Genentech

The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p

Key Points: 
  • The inavolisib combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 57% compared to palbociclib and fulvestrant alone (15.0 months vs 7.3 months; hazard ratio [HR]=0.43, 95% CI: 0.32-0.59, p
  • The discontinuation rate in the inavolisib treatment group was 6.8% compared to 0.6% for palbociclib and fulvestrant alone.
  • Inavolisib, an investigational oral therapy, is currently being investigated in three Phase III clinical studies in people with PIK3CA-mutated locally advanced or metastatic breast cancer (INAVO120, INAVO121, INAVO122).
  • PIK3CA mutations are found in approximately 40% of HR-positive breast cancers and can lead to mutated PI3Kα protein, which contributes to uncontrolled tumor growth, disease progression and resistance to endocrine-based treatment.