Obinutuzumab

Generic Name
Obinutuzumab
Brand Names
Gazyva, Gazyvaro
Drug Type
Biotech
Chemical Formula
-
CAS Number
949142-50-1
Unique Ingredient Identifier
O43472U9X8
Background

Obinutuzumab is a humanized monoclonal antibody used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia. It was approved by the FDA in November 2013 and is marketed under the brand name Gazyva. There is a black box warning of fatal Hepatitis B Virus (HBV) reactivation and fatal Progressive Multifocal Le...

Indication

Obinutuzumab is used as a combination treatment with chlorambucil to treat patients with untreated chronic lymphocytic leukemia.

Associated Conditions
Refractory Follicular Lymphoma, Previously untreated Chronic lymphocytic leukemia
Associated Therapies
-
biopharmadive.com
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ASH24: Leukemia drug sequencing, sickle cell questions and a new kind of CAR-T

ASH meeting featured studies on BTK inhibitors in CLL, including Jaypirca's Phase 3 trial showing improved progression-free survival and fewer side effects. AstraZeneca's Calquence combined with Venclexta reduced progression risk by 35%. Pfizer's Oxbryta withdrawal due to safety concerns raised questions on sickle cell drug approvals. Bristol Myers Squibb presented positive survival data for its GPRC5D-targeted CAR-T therapy, arlo-cel, in multiple myeloma.
onclive.com
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Piecing Together the Proper BTK Usage in CLL

Nicole Lamanna discussed the progression in CLL patients with covalent BTK inhibitors and venetoclax, emphasizing the need for new treatments. She highlighted clinical trials and CAR T-cell therapy options, including the TRANSCEND CLL 004 trial with lisocabtagene ciloleucel, and the CaDAnCE-101 trial with BGB-16673. Lamanna also presented the EPCOR trial with epcoritamab-bysp, suggesting bispecific antibodies as potential next steps for CLL treatment.

Roche/Genentech's Gazyva Poised to Transform Lupus Nephritis Treatment After Positive

GSK’s Benlysta and Aurinia’s Lupkynis have advanced lupus nephritis treatment, but unmet needs persist. Roche’s Gazyva (obinutuzumab) showed potential in Phase III REGENCY trial, addressing key challenges like proteinuria and steroid dependence. Gazyva could become the second biologic for LN, challenging Benlysta’s market dominance. Lupkynis remains a niche option for high proteinuria, but Gazyva’s trial success may shift this dynamic. Future competition from AZ’s Saphnelo and Novartis’ ianalumab is expected post-2025.
globenewswire.com
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Roche/Genentech's Gazyva Poised to Transform Lupus

GSK’s Benlysta and Aurinia’s Lupkynis have advanced lupus nephritis treatment, but unmet needs remain. Roche’s Gazyva (obinutuzumab) showed significant complete renal response in Phase III REGENCY trial, potentially addressing key challenges like proteinuria and steroid dependence. If approved, Gazyva could rival Benlysta and Lupkynis, with market impact expected before competition from AZ’s Saphnelo and Novartis’ ianalumab.
biospace.com
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Kezar's Lupus Trial Paused After Four Patient Deaths

FDA placed a clinical hold on Kezar Life Sciences' zetomipzomib development for lupus nephritis after 4 patients died in Phase IIb PALIZADE trial. Kezar observed common symptoms and proximity to dosing in the deaths and other serious adverse events, leading to voluntary suspension of enrollment and dosing. The company is investigating potential risk mitigation strategies and expects a formal FDA letter. Kezar continues zetomipzomib development for autoimmune hepatitis unaffected by the hold.
biopharmadive.com
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J&J builds case for Talvey; FDA panel questions PD-1 drugs for certain cancers

J&J's Talvey shows promise in multiple myeloma trials; FDA advisory committee votes against cancer immunotherapy use in certain digestive tract cancers; AbbVie's acquisition of Cerevel Therapeutics yields positive Parkinson's drug results; Roche's Gazyva succeeds in lupus nephritis Phase 3 study; Biogen terminates agreement with Sage Therapeutics over failed essential tremor drug; Enanta Pharmaceuticals' EDP-323 shows rapid antiviral effect against RSV.
biospace.com
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Roche Looks to Push Gazyva Into Lupus Nephritis With Promising Late-Stage Data

Genentech announced Gazyva met primary efficacy endpoint in Phase III REGENCY study for lupus nephritis, showing statistically significant and clinically meaningful benefits. Gazyva, a monoclonal antibody targeting CD20, also met key secondary endpoints, including reduction in corticosteroid use and improvement in proteinuric response. Roche plans to present data to FDA and other health authorities for potential approvals.
endpts.com
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Gazyva hits primary endpoint in late-stage kidney disease trial

Genentech plans to expand Gazyva's label after positive Phase 3 REGENCY study data in lupus nephritis, showing higher complete renal response rates with Gazyva plus standard therapy compared to standard therapy alone. Data shared with FDA aims to make Gazyva available 'as soon as possible'. Lupus nephritis affects 1.7 million globally, often progressing to end-stage kidney disease. Gazyva, already approved for lymphoma, is also being investigated in other conditions.
lupus.org
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Positive Phase III Clinical Trial Results Announced for Gazyva for the Treatment of Lupus Nephritis

Genentech announced positive Phase III REGENCY study results for Gazyva (Obinutuzumab) in active lupus nephritis (LN), showing higher complete renal response rates with Gazyva plus standard therapy compared to placebo. Gazyva targets CD20 on B cells to reduce inflammation and kidney damage, potentially preventing end-stage renal disease. The study involved 271 participants and met its primary endpoint. Gazyva is also under study for other conditions and has FDA Breakthrough Therapy designation.
gene.com
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Press Releases | Wednesday, Sep 25, 2024

Genentech announced positive Phase III REGENCY study results for Gazyva, showing it plus standard therapy achieved a higher complete renal response rate in active lupus nephritis patients compared to standard therapy alone, with no new safety signals.
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