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Phase 3
Development Phase
0
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0
Historical Events
11
Regulatory Approvals
No catalyst events have been recorded for this drug yet.
1 competitor in Metastatic Colorectal Adenocarcinoma
View Full LandscapeTarget Indication
Metastatic Colorectal Adenocarcinoma
Clinical Trial
NCT03043313Last updated: 12/29/2025
Hervelous
Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)
View on EMATuznue
Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC)
View on EMADazublys
Breast cancer Metastatic breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive metastatic breast cancer (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor-positive MBC, not previously treated with trastuzumab. Early breast cancer Dazublys is indicated for the treatment of adult patients with HER2-positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). following adjuvant chemotherapy with doxorubicin and cyclophosphamide in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Dazublys therapy for locally advanced (including inflammatory) disease or tumors> 2 cm in diameter (see sections 4.4 and 5.1). Dazublys should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Dazublys in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatme
View on EMATuznue
Metastatic breast cancer (MBC) For the treatment of adult patients with HER2-positive MBC: 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. 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 in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab Early breast cancer (EBC) For the treatment of adult patients with HER2-positive EBC: following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant HD201 therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. HD201 should only be used in patients with MBC or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer (MGC) In combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. HD201 should only be
View on EMAHerwenda
Treatment of metastatic and early breast cancer and metastatic gastric cancer (MGC).
View on EMAZercepac
Breast cancer Metastatic breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Zercepac is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Zercepac therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Zercepac in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive met
View on EMAOgivri
Breast cancer Metastatic breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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 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 in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Ogivri is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Ogivri therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Ogivri should only be used in patients with metastatic or EBC whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Ogivri in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarci
View on EMATrazimera
Breast cancer Metastatic breast cancer Trazimera is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer: (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Trazimera is indicated for the treatment of adult patients with HER2 positive early breast cancer. (EBC). following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Trazimera therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Trazimera should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Trazimera in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarc
View on EMAKanjinti
Metastatic breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Kanjinti is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Kanjinti should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Kanjinti 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
View on EMAHerzuma
Breast cancer Metastatic breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Herzuma is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC): following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Herzuma therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter. Herzuma should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Herzuma in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of th
View on EMAOntruzant
Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): 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. 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. in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable). following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter. Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay. Metastatic gastric cancer Ontruzant in combination with capecitabine or 5?fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinom
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