Trastuzumab
The first targeted antibody for a solid tumour (1998), which turned HER2-positive breast cancer from the worst subtype into one of the most treatable.
Metastatic (1998) and adjuvant (2006; HERA, NSABP B-31/N9831 with ~37% reduction in death). With pertuzumab (CLEOPATRA, APHINITY) as dual blockade; subcutaneous Phesgo. Backbone of T-DM1 and T-DXd antibodies. Biosimilars since 2017.
1.Antibody binds domain IV of HER2
- Route
- IV infusion (subcutaneous Herceptin Hylecta / Phesgo with pertuzumab available)
- Schedule
- 8 mg/kg loading then 6 mg/kg every 3 weeks (or 4 then 2 mg/kg weekly); 1 year adjuvant
- Dose modifications
- Hold for LVEF drop ≥16 points or below normal
- Monitoring
- LVEF at baseline and every 3 months during therapy; infusion reactions
Source: www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications. Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9355 for Herceptin; each biosimilar has its own Q-code. Under the Inflation Reduction Act, Part B coinsurance on a biosimilar is calculated on the reference product's price, so biosimilars usually cost the patient less.
- Commercial insurance
- step therapy common
Most commercial plans and PBM medical-benefit programmes now require a preferred trastuzumab biosimilar (e.g. Kanjinti, Ogivri, Trazimera) before the originator; prior authorisation confirms HER2 status.
- Assistance programmes
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · FDA: Biosimilars. Not medical or financial advice; verify with your plan.
- Appraised for
- HER2-positive advanced breast cancer
- Notes
- Adjuvant early breast cancer: TA107 (2006). HER2-positive gastric cancer: TA208 (2010). Biosimilars and the subcutaneous form are used under the same guidance and have cut the NHS price substantially.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA34 · SMC advice: trastuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
- 25 Sept 1998ApprovalUS
HER2+ metastatic breast cancer: first targeted antibody for a solid tumour source
- 16 Nov 2006ApprovalUS
Adjuvant HER2+ early breast cancer (HERA, NSABP B-31/N9831) source
- 20 Oct 2010ApprovalUS
HER2+ metastatic gastric cancer (ToGA) source
- 1 Dec 2017ApprovalUS
First trastuzumab biosimilar (Ogivri) source
- 28 Feb 2019ApprovalUS
Subcutaneous trastuzumab-hyaluronidase (Herceptin Hylecta) source
- 29 Jun 2020ApprovalUS
Phesgo (pertuzumab, trastuzumab, hyaluronidase) subcutaneous source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 1998 | HER2+ metastatic breast cancer |
| US | 2006 | Adjuvant HER2+ breast cancer |
| US | 2010 | HER2+ gastric cancer |
| Adverse event |
|---|
| Cardiomyopathy / LVEF decline |
| Infusion reactions |
| Fever |
| Nausea |
| Diarrhoea |
| Pulmonary toxicity (rare) |
Adjuvant trials: ~2-4% symptomatic heart failure with anthracyclines. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United Statesgeneric | Medicare Part B; five biosimilars available since 2019, roughly 15-35% below reference price | not disclosed | genentech-access.com |
| United Kingdom | NICE: standard of care; biosimilars widely used | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Trastuzumab" OR ABSTRACT:"Trastuzumab" OR TITLE:"Herceptin" OR ABSTRACT:"Herceptin" OR TITLE:"and biosimilars" OR ABSTRACT:"and biosimilars" OR TITLE:"Phesgo with pertuzumab" OR ABSTRACT:"Phesgo with pertuzumab") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductPertuzumab
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