Rituxan Hycela® (rituximab; hyaluronidase)

BL 761064

Rituxan Hycela® (rituximab; hyaluronidase)

BL 761064

U.S. License Holder:

Genentech Inc.

Date of License:

June-22-2017

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

RITUXAN HYCELA (hyaluronidase; rituximab) is a combination of rituximab, a CD20 directed cytolytic antibody, and hyaluronidase human, an endoglycosidase, indicated for the treatment of adult patients with:

Follicular Lymphoma (FL): Relapsed or refractory, follicular lymphoma as a single agent; Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy;

Diffuse Large B-cell Lymphoma (DLBCL): Previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens;

Chronic Lymphocytic Leukemia (CLL): Previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide (FC).

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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