Rituxan® (Rituximab)
Full Prescribing Information, including Boxed Warnings
| Date |
Event |
|
| 1975 |  |
Therapeutic antibodies are developed by scientists Cesar Milstein and Georges Kohler |
| 1976 | |
Genentech is founded, marking the birth of the biotech industry |
| 1984 |
|
Magic Bullets, a book about the use of therapeutic antibodies being used to treat cancer, is published |
| 1984 |
|
Milstein and Kohler win the Nobel Prize |
| 1995 |
|
Genentech and IDEC sign collaboration to develop and commercialize Rituxan |
| 1996 |
|
Pivotal Phase III data on Rituxan is presented at the American Society of Hematology (ASH) meeting |
| 1997 |
|
The FDA approves Rituxan, the first therapeutic antibody approved for the treatment of cancer (relapsed or refractory, CD20+, B-cell low-grade non-Hodgkin’s lymphoma) |
| 1998 |
|
Rituxan is approved in the European Union under the trade name MabThera® |
| 2001 |
|
A supplemental Biological License Application (sBLA) is approved by the FDA for Rituxan adding several new uses, including:
|
| 2002 |
|
New England Journal of Medicine publishes data from the Phase III GELA study demonstrating that Rituxan plus CHOP chemotherapy may offer previously-untreated patients the potential for a significant improvement in event-free and overall survival compared to CHOP alone – represents the first improvement in survival in this patient population in more than 25 years |
| 2002 |
|
Data from studies featuring Rituxan in the treatment of rheumatoid arthritis is presented at the American College of Rheumatology (ACR) annual meeting |
| 2002 |
|
More than 190 abstracts on Rituxan presented at the ASH annual meeting |
| 2003 |
|
Biogen, Inc. and IDEC Pharmaceuticals Corporation merge to form Biogen Idec Inc. |
| 2003 |
|
More than 200 abstracts presented at ASH |
| 2004 |
|
More than 250 abstracts presented at ASH |
|
New England Journal of Medicine publishes the results of a Phase IIa study of Rituxan in patients with moderate-to-severe rheumatoid arthritis (RA) | |
|
DANCER, a Phase IIb study of Rituxan in RA, met its primary endpoint | |
| 2005 |
|
REFLEX, a Phase III clinical study of Rituxan in RA, met its primary endpoint |
| 2006 |
|
On February 10, 2006 Rituxan is approved for the first-line treatment of patients with diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. |
|
On February 28, 2006 Rituxan is approved in combination with methotrexate (MTX) to reduce signs and symptoms in adult patients with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. | |
|
On September 29, 2006 Rituxan is approved for the treatment of patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) as a single agent; for previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens; for previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy; and for the treatment of non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy. | |