Herceptin® (Trastuzumab)
Full Prescribing Information, including Boxed Warnings
| Date |
Event |
|
|---|---|---|
| May 2008 |  |
The FDA approved two new Herceptin-containing regimens for the adjuvant treatment of HER2-positive node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer based on the results of the BCIRG 006 study. The first regimen is in combination with docetaxel and carboplatin, (also known as TCH for Taxotere®, carboplatin, and Herceptin) which does not contain an anthracycline component. The second is part of a treatment regimen containing anthracycline (doxorubicin), cyclophosphamide, and docetaxel (AC-TH). The approval of the non-anthracycline TCH regimen added an important treatment option for patients as it reduced the rate of congestive heart failure (0.4% vs. 2%) as compared to the Herceptin anthracycline-containing regimen in the 006 study and significantly reduced the relative risk of recurrence by one-third, compared to chemotherapy alone. In comparison to AC-TH, TCH provided a similarly effective treatment option with less cardiotoxicity, which may potentially allow more patients to benefit from Herceptin therapy. |
| January 2008 | |
Based on the HERA one-year data, the FDA approved Herceptin
as a single agent for the adjuvant treatment of HER2-positive, node-negative
(ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multi-modality, anthracycline-based therapy. Herceptin also may be administered as a single agent in an every-three-week dosing schedule for one year. |
| June 2007 | |
Genentech submitted two sBLAs to the FDA based on the BCIRG 006 trial, which may expand the use of Herceptin in the adjuvant treatment for HER2-positive breast cancer. The first is part of a treatment regimen of doxorubicin and cyclophosphamide followed by Taxotere and Herceptin (AC-TH). The second is part of a non-anthracycline regimen of docetaxel and carboplatin (also known as TCH for Taxotere®, carboplatin, and Herceptin). |
| December 2006 | |
Genentech submitted an sBLA with the FDA based on the global HERA study, which may expand the indication of Herceptin in the adjuvant treatment of
HER2-positive breast cancer to include patients with high-risk, node-negative disease, after different types of anthracycline-based chemotherapies and a different
dosing regimen. |
| November 2006 | |
The FDA approved Herceptin as part of a treatment regimen
containing doxorubicin, cyclophosphamide, and paclitaxel for the adjuvant treatment
of patients with HER2-positive, node-positive breast cancer based on the joint
analysis studies. |
| February 2006 | |
Genentech filed a supplemental Biologics License Application (sBLA) with the FDA for Herceptin for the adjuvant treatment of HER2-positive breast cancer based on results from the joint analysis of the NSABP and NCCTG trials. |
| August 2005 |
|
Genentech issued a letter to healthcare providers informing them of updated cardiotoxicity information related to the use of Herceptin, obtained from the Phase III NSABP study (B-31). |
| May 2005 |
|
Results from a joint analysis of the two Phase III NSABP and NCCTG clinical trials evaluating the addition of Herceptin to standard therapy for the adjuvant treatment of HER2-positive breast cancer were presented at the ASCO annual meeting. |
| August 2002 | |
Genentech received FDA approval to include information about a breast cancer gene-detection test method called FISH (fluorescence in situ hybridization) in the Herceptin product labeling. |
| December 2001 |
|
Genentech received approval from the FDA to include information about the increase in median survival for Herceptin patients in the product labeling. |
| March 2001 |
|
Further data from a pivotal Phase III clinical trial were published in the New England Journal of Medicine (NEJM) that showed a significant increase in survival for women with HER2-positive metastatic breast cancer who received Herceptin and
chemotherapy over chemotherapy alone. |
| December 2000 |
|
Enrollment of Phase III clinical trials evaluating the potential use of Herceptin for the adjuvant treatment of HER2-positive breast cancer was announced.
Adjuvant therapy was given to women with early-stage (localized) breast cancer who have had initial treatment — surgery with or without radiation therapy — with the goal of reducing the risk of cancer recurrence and/or the occurrence of metastatic disease.
Among them were two studies sponsored by the National Cancer Institute (NCI), part of
the National Institutes of Health, and conducted by a network of researchers led by the
National Surgical Adjuvant Breast and Bowel Project (NSABP) and the North Central
Cancer Treatment Group (NCCTG). |
| August 2000 |
|
European Commission approved Herceptin for the treatment of HER2-positive metastatic breast cancer. |
| May 2000 |
|
Genentech issued a letter to healthcare providers about reports of serious adverse events, including hypersensitivity, infusion and pulmonary reactions. |
| August 1999 |
|
Switzerland was the first regulatory authority in Europe to grant marketing approval for Herceptin. |
| September 1998 |
|
Herceptin received FDA approval for use in women with metastatic breast cancer who have tumors that overexpress the HER2 protein. It is indicated for treatment of patients both as first-line therapy in combination with paclitaxel and as a single agent for those who have received one or more chemotherapy regimens. |
| July 1998 |
|
Roche and Genentech signed a licensing agreement giving Roche exclusive marketing rights for Herceptin outside of the United States. |
| May 1998 |
|
Results from a Phase III investigational clinical trial for Herceptin were presented at the American Society of Clinical Oncology (ASCO) annual meeting. Results showed that Herceptin, in combination with chemotherapy, slowed the progression of cancer and increased tumor shrinkage. Genentech submitted application for FDA approval of Herceptin. |
| March 1998 |
|
FDA designated Herceptin as a "Fast Track" product for the treatment of metastatic breast cancer. Genentech announced an agreement with DAKO to develop a diagnostic kit to screen breast cancer patients for HER2 protein overexpression to determine patient eligibility for Herceptin. |
| March 1997 |
|
Phase III pivotal combination trials for Herceptin® (Trastuzumab) were completed. |
| June 1995 |
|
Enrollment of Phase III pivotal combination trial began. |
| 1993 |
|
Phase II clinical trials were initiated. |
| 1992 |
|
Genentech filed an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) and Phase I clinical trials were initiated. |
| 1990 |
|
Len Presta and Paul Carter of Genentech humanized an antibody directed at HER2. |
| 1987 |
|
Dr. Dennis Slamon and colleagues at UCLA published in Science the link between HER2 overexpression with a more aggressive type of breast cancer in approximately 25 percent of patients for the first time. |
| 1985 |
|
HER2 gene was cloned. |
| 1975 |
|
Scientists Georges Köhler and César Milstein discovered the potential of using antibodies in vitro to fight disease. |