BLA 761064, held by Genentech Inc. Rituximab; Hyaluronidase (Human Recombinant).
As of Nov 13, 2026, BLA 761064 (Rituxan Hycela), held by Genentech Inc, was first approved by FDA on Jun 22, 2017, with 5 approved supplements and 0 published complete response letters.
RITUXAN HYCELA 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) Previo…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 22, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Jun 22, 2017 | Supplement 1New formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rituxan Hycela1400MG and 23400UNITS/11.7ML · solution;subcutaneous | Rituximab; Hyaluronidase (Human Recombinant) | Rx |
| Rituxan Hycela1600MG and 26800UNITS/13.4ML · solution;subcutaneous | Rituximab; Hyaluronidase (Human Recombinant) | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 10, 2021 | Supplement 13Labeling · Standard review | Approved | |
| May 5, 2020 | Supplement 8Labeling · Standard review | Approved | |
| May 5, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Dec 19, 2019 | Supplement 9Labeling · Standard review | Approved | |
| Jun 22, 2017 | Original applicationNew formulation or manufacturer · Standard review | Approved | |
| Jun 22, 2017 | Supplement 1New formulation or manufacturer · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
