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Gazyva Approval History

FDA Approved: Yes (First approved November 1, 2013)
Brand name: Gazyva
Generic name: obinutuzumab
Dosage form: Injection
Company: Genentech, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Follicular Lymphoma

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody indicated for the combination treatment of patients with chronic lymphocytic leukemia and follicular lymphoma.

Development History and FDA Approval Process for Gazyva

DateArticle
Jan 28, 2019Approval FDA Approves Imbruvica (ibrutinib) Plus Obinutuzumab as First Non-Chemotherapy Combination Regimen for Treatment-Naïve Patients with Chronic Lymphocytic Leukemia
Nov 16, 2017Approval FDA Approves Genentech’s Gazyva for Previously Untreated Advanced Follicular Lymphoma
Feb 26, 2016Approval FDA Approves Genentech’s Gazyva (obinutuzumab) for Certain People with Previously Treated Follicular Lymphoma
Nov  1, 2013Approval FDA Approves Gazyva for Chronic Lymphocytic Leukemia

Further information

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