Gazyva® (obinutuzumab)

BL 125486

Gazyva® (obinutuzumab)

BL 125486

U.S. License Holder:

Genentech

Date of License:

November-01-2013

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

GAZYVA (obinutuzumab) is a CD20-directed cytolytic antibody and is indicated:

In combination with chlorambucil, for the treatment of patients with previously untreated chronic lymphocytic leukemia;

In combination with bendamustine followed by Gazyva monotherapy, for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen

In combination with chemotherapy followed by Gazyva monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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