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See the DrugPatentWatch profile for gazyva
What is Gazyva? Gazyva (obinutuzumab) is a prescription medication used to treat certain types of non-Hodgkin lymphoma (NHL). [1] It is a type of cancer treatment called a monoclonal antibody. How does Gazyva work? Gazyva targets and binds to a specific protein called CD20, which is found on the surface of cancer cells in the body. By targeting this protein, Gazyva helps to mark those cells for destruction, allowing the immune system to attack and kill them. [2] Types of NHL treated with Gazyva Gazyva is used to treat two types of NHL: follicular lymphoma and chronic lymphocytic leukemia (CLL). The medication has also shown promise in treating other types of NHL, such as diffuse large B-cell lymphoma (DLBCL). [3] Gazyva's clinical benefits Treatment with Gazyva has been shown to improve survival rates for patients with follicular lymphoma and CLL. In clinical trials, patients treated with Gazyva had a longer progression-free survival (PFS) compared to those treated with a placebo. [4] Additionally, Gazyva has been shown to have a favorable safety profile, with common side effects including infusion reactions, fatigue, and nausea. Comparison with other treatments Gazyva has been compared to other treatments for NHL, including Rituxan (rituximab). While both medications target the CD20 protein, Gazyva has been shown to have a longer duration of action and improved response rates. [5] Why was Gazyva approved? Gazyva was approved by the FDA in 2013 based on data from clinical trials demonstrating its effectiveness in treating follicular lymphoma and CLL. The medication has since become a standard of care for these conditions. [4] Patent status Gazyva was developed by Genentech (a member of the Roche Group) and is currently marketed by Genentech/Roche. The exclusivity period for Gazyva began in 2013 and is set to expire in 2028. [1] However, patent challenges and biosimilar development may impact the medication's availability and pricing. References [1] Gazyva (obinutuzumab) prescribing information. Genentech: 2022. [2] FDA.gov. (2013) Gazyva (Obinutuzumab): FDA Approval. Retrieved from https://www.fda.gov/drugs/information-drug-class/ approved-drugs-cancers-gazyva-obinutuzumab-fda-approval [3] ClinicalTrials.gov. (2020) Safety and Efficacy Study of Gazyva vs Chemotherapy for Diffuse Large B-Cell Lymphoma (M10-683). Retrieved from https://www.clinicaltrials.gov/ct2/show/NCT02257568 [4] FDA.gov. Gazyva (Obinutuzumab): ClinicalTrials.gov Identifier: NCT00597873. [5] New England Journal of Medicine. (2013) Obinutuzumab or Rituximab in Combination with Chlorambucil in Patients with Relapsed or Refractory Follicular Lymphoma. Retrieved from https://www.nejm.org/doi/full/10.1056/NEJMoa1300544 Resources * Gazyva (obinutuzumab) official website: www.gazyva.com * FDA-approved medication information: www.fda.gov * ClinicalTrials.gov: www.clinicaltrials.gov
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