HER2
33 EU-approved indications of 11 drugs need a HER2 result, in 6 tumour types, most of them in breast cancer, gastric and GEJ adenocarcinoma and non-small cell lung cancer.
Approved indications33
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Non-small cell lung cancer1 | ||||
Enhertuconditional | Monotherapy | 2L advanced | After platinum-based chemotherapy with or without immunotherapy | |
| Triple-negative breast cancer1 | ||||
Datroway | Triple-negative (ER-negative, PR-negative, HER2-negative) | Monotherapy | 1L advanced | Not candidates for PD-1/PD-L1 inhibitor therapy |
| Breast cancer26 | ||||
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Neoadj. | Locally advanced, inflammatory, or early stage; high risk of recurrence |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Neoadj. | Locally advanced, inflammatory, or early stage; high risk of recurrence |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + neoadjuvant chemotherapy | Neoadj. | Then adjuvant monotherapy after surgery; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
Nerlynx | IHC 3+ or IHC 2+/ISH-positive, HR-positive | Monotherapy | Adj. early | After adjuvant trastuzumab-based therapy completed less than one year ago |
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and chemotherapy | Adj. early | High risk of recurrence |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + chemotherapy | Adj. early | High risk of recurrence |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + docetaxel and carboplatin | Adj. early | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + paclitaxel or docetaxel | Adj. early | After adjuvant chemotherapy with doxorubicin and cyclophosphamide |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. early | Following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. | After neoadjuvant Herceptin + chemotherapy and surgical resection; Locally advanced (including inflammatory) disease or tumours > 2 cm in diameter |
Kadcyla | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | Adj. early | After neoadjuvant taxane-based and HER2-targeted therapy; Residual invasive disease, in the breast and/or lymph nodes |
Perjeta | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and docetaxel | 1L advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
Phesgo | IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1L advanced | No prior anti-HER2 therapy or chemotherapy for metastatic disease |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + docetaxel | 1L metastatic | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + paclitaxel | 1L metastatic | Anthracycline is not suitable |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | + pertuzumab | 1L advanced | None |
Tyverb | IHC 3+ or IHC 2+/ISH-positive | + capecitabine | 2L advanced | Progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting |
Tyverb | IHC 3+ or IHC 2+/ISH-positive, HR-negative | + trastuzumab | 2L metastatic | Progressed on prior trastuzumab therapy(ies) in combination with chemotherapy |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | After one or more prior anti-HER2-based regimens |
Enhertuconditional | IHC 1+ or IHC 2+/ISH-negative or IHC 0 with membrane staining (faint, incomplete, ≤10% of tumour cells), HER2-low or HER2-ultralow, HR-positive | Monotherapy | 2L advanced | After at least one endocrine therapy in the metastatic setting; Not considered suitable for endocrine therapy as the next line of treatment |
Enhertuconditional | IHC 1+ or IHC 2+/ISH-negative, HER2-low | Monotherapy | 2L advanced | After prior chemotherapy in the metastatic setting or disease recurrence during or within 6 months of completing adjuvant chemotherapy |
Kadcyla | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | After prior trastuzumab and a taxane, separately or in combination; and either prior therapy for locally advanced or metastatic disease, or disease recurrence during or within six months of completing adjuvant therapy |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 3L+ metastatic | After at least two prior chemotherapy regimens for metastatic disease including an anthracycline and a taxane (unless unsuitable); failed hormonal therapy for hormone receptor-positive disease (unless unsuitable) |
Tukysa | IHC 3+ or IHC 2+/ISH-positive | + trastuzumab and capecitabine | 3L+ advanced | After at least 2 prior anti-HER2 treatment regimens |
Tyverb | IHC 3+ or IHC 2+/ISH-positive, HR-positive | + an aromatase inhibitor | Any line metastatic | Postmenopausal women; not currently intended for chemotherapy |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive, HR-positive | + aromatase inhibitor | Any line metastatic | No prior trastuzumab; Postmenopausal |
| Gastric and GEJ adenocarcinoma3 | ||||
Keytruda | PD-L1 CPS ≥ 1; HER2 IHC 3+ or IHC 2+/ISH-positive | + trastuzumab, fluoropyrimidine and platinum-containing chemotherapy | 1L advanced | None |
Herceptin, Tuznue | IHC 3+ or IHC 2+/ISH-positive | + capecitabine or 5-fluorouracil, and cisplatin | 1L metastatic | None |
Enhertuconditional | IHC 3+ or IHC 2+/ISH-positive | Monotherapy | 2L advanced | After prior trastuzumab-based regimen |
| Biliary tract cancer1 | ||||
Ziiheraconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After at least one prior line of systemic therapy |
| Solid tumours, tumour-agnostic1 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
HER2 by tumour
Label wording33
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
- Trastuzumab (Herceptin, Tuznue)
as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
- Trastuzumab (Herceptin, Tuznue)
in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
- Trastuzumab (Herceptin, Tuznue)
in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
- Trastuzumab (Herceptin, Tuznue)
in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
- Trastuzumab (Herceptin, Tuznue)
following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1).
- Trastuzumab (Herceptin, Tuznue)
following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
- Trastuzumab (Herceptin, Tuznue)
in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
- Trastuzumab (Herceptin, Tuznue)
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- Trastuzumab (Herceptin, Tuznue)
in combination with neoadjuvant chemotherapy followed by adjuvant Herceptin therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
- Trastuzumab (Herceptin, Tuznue)
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
- Trastuzumab deruxtecan (Enhertu)
Enhertu in combination with pertuzumab is indicated for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer (for biomarker-based patient selection, see section 4.2).
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
- Trastuzumab deruxtecan (Enhertu)
• hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment (see sections 4.2 and 5.1).
- Trastuzumab deruxtecan (Enhertu)
• HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4.2).
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
- Trastuzumab deruxtecan (Enhertu)
Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options (see sections 4.4 and 5.1; for biomarker-based patient selection, see section 4.2).
- Pertuzumab (Perjeta)
the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab (Perjeta)
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab (Perjeta)
Perjeta is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Datopotamab deruxtecan (Datroway)
Datroway as monotherapy is indicated for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy (see section 5.1).
- Trastuzumab emtansine (Kadcyla)
Kadcyla, as a single agent, is indicated for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy.
- Trastuzumab emtansine (Kadcyla)
Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
- Zanidatamab (Ziihera)
Ziihera as monotherapy is indicated for the treatment of adults with unresectable locally advanced or metastatic HER2-positive (IHC3+) biliary tract cancer (BTC) previously treated with at least one prior line of systemic therapy (for biomarker-based patient selection, see section 4.2).
- Lapatinib (Tyverb)
in combination with capecitabine for patients with advanced or metastatic disease with progression following prior therapy, which must have included anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
- Lapatinib (Tyverb)
in combination with trastuzumab for patients with hormone receptor-negative metastatic disease that has progressed on prior trastuzumab therapy(ies) in combination with chemotherapy (see section 5.1).
- Lapatinib (Tyverb)
in combination with an aromatase inhibitor for postmenopausal women with hormone receptor positive metastatic disease, not currently intended for chemotherapy.
- Tucatinib (Tukysa)
TUKYSA is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2-positive locally advanced or metastatic breast cancer who have received at least 2 prior anti-HER2 treatment regimens.
- Pertuzumab + trastuzumab (Phesgo)
the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab + trastuzumab (Phesgo)
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
- Pertuzumab + trastuzumab (Phesgo)
Phesgo is indicated for use in combination with docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
- Neratinib (Nerlynx)
Nerlynx is indicated for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago.