Difference between revisions of "Trastuzumab (Herceptin)"

Revision as of 20:40, 3 May 2021

General information

Class/mechanism: HER2/neu receptor antagonist, humanized IgG1 kappa monoclonal antibody. Trastuzumab binds to the extracellular domain of HER2/erbB2 (human epidermal growth factor receptor 2), which is overexpressed in certain malignancies. Trastuzumab helps to mediate antibody-dependent cellular cytotoxicity (ADCC) preferentially against cells that overexpress HER2.^[1]^[2]^[3]
Route: IV
Extravasation: neutral

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

HER2+ breast cancer

9/25/1998: Initial FDA approval as a single agent for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease.
8/28/2002: Approved in combination with paclitaxel for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. (Approval extended to first-line metastatic setting)
11/16/2006: Label revised: trastuzumab as part of a treatment regimen containing doxorubicin, cyclophosphamide, and paclitaxel is indicated for the adjuvant treatment of patients with HER2-overexpressing, node-positive breast cancer. (Approval extended to adjuvant setting; based on APHINITY, BCIRG 006, NeoSphere, TRYPHAENA, BERENICE)
1/18/2008: Labeling simplified: indicated for the treatment of HER2 overexpressing breast cancer. (Approval extended to all settings)

HER2+ gastric/gastroesophageal cancer

10/20/2010: Approved in combination with cisplatin and a fluoropyrimidine (capecitabine or 5-fluorouracil), for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal (GE) junction adenocarcinoma, who have not received prior treatment for metastatic disease. (New disease entity; based on ToGA)

Also known as

Brand names: Biceltis, CANMab, Herceptin, Herclon, Hertraz

References

[insert-1] 1.0 ^1.1 Trastuzumab (Herceptin) package insert

[2] Trastuzumab (Herceptin) package insert (locally hosted backup)

[3] Herceptin manufacturer's website

[4] Trastuzumab (Herceptin) manufacturer's patient website

[5] Trastuzumab (Herceptin) patient drug information (Chemocare)

[6] Trastuzumab (Herceptin) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]

[6]

@@ Line 21: / Line 21: @@
 *9/25/1998: Initial FDA approval as a single agent for treatment of patients with metastatic [[breast cancer]] whose tumors [[Biomarkers#Overexpression|overexpress]] the [[Biomarkers#HER2|HER2 protein]] and who have received one or more chemotherapy regimens for their metastatic disease.
 *8/28/2002: Approved in combination with [[Paclitaxel (Taxol) | paclitaxel]] for treatment of patients with metastatic [[breast cancer]] whose tumors [[Biomarkers#Overexpression|overexpress]] the [[Biomarkers#HER2|HER2 protein]] and who have not received chemotherapy for their metastatic disease. ''(Approval extended to first-line metastatic setting)
-*11/16/2006: Label revised: trastuzumab as part of a treatment regimen containing [[Doxorubicin (Adriamycin) | doxorubicin]], [[Cyclophosphamide (Cytoxan) | cyclophosphamide]], and [[Paclitaxel (Taxol) | paclitaxel]] is indicated for the adjuvant treatment of patients with [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|overexpressing]], node-positive [[breast cancer]]. ''(Approval extended to adjuvant setting)
+*11/16/2006: Label revised: trastuzumab as part of a treatment regimen containing [[Doxorubicin (Adriamycin) | doxorubicin]], [[Cyclophosphamide (Cytoxan) | cyclophosphamide]], and [[Paclitaxel (Taxol) | paclitaxel]] is indicated for the adjuvant treatment of patients with [[Biomarkers#HER2|HER2]]-[[Biomarkers#Overexpression|overexpressing]], node-positive [[breast cancer]]. ''(Approval extended to adjuvant setting; based on APHINITY, BCIRG 006, NeoSphere, TRYPHAENA, BERENICE)
 *1/18/2008: Labeling simplified: indicated for the treatment of [[Biomarkers#HER2|HER2]] [[Biomarkers#Overexpression|overexpressing]] [[breast cancer]]. ''(Approval extended to all settings)
 ===[[Gastric cancer|HER2+ gastric/gastroesophageal cancer]]===
-*10/20/2010: Approved in combination with cisplatin and a fluoropyrimidine (capecitabine or 5-fluorouracil), for the treatment of patients with [[Biomarkers#HER2|HER2]] [[Biomarkers#Overexpression|overexpressing]] metastatic [[Gastric cancer |gastric or gastroesophageal (GE) junction adenocarcinoma]], who have not received prior treatment for metastatic disease. ''(New disease entity)
+*10/20/2010: Approved in combination with cisplatin and a fluoropyrimidine (capecitabine or 5-fluorouracil), for the treatment of patients with [[Biomarkers#HER2|HER2]] [[Biomarkers#Overexpression|overexpressing]] metastatic [[Gastric cancer |gastric or gastroesophageal (GE) junction adenocarcinoma]], who have not received prior treatment for metastatic disease. ''(New disease entity; based on ToGA)
 ==Also known as==