Mylotarg União Europeia - inglês - EMA (European Medicines Agency)

mylotarg

pfizer europe ma eeig - gemtuzumab ozogamicin - leukemia, myeloid, acute - antineoplastic agents - mylotarg is indicated for combination therapy with daunorubicin (dnr) and cytarabine (arac) for the treatment of patients age 15 years and above with previously untreated, de novo cd33-positive acute myeloid leukaemia (aml), except acute promyelocytic leukaemia (apl).

Trazimera União Europeia - inglês - EMA (European Medicines Agency)

trazimera

pfizer europe ma eeig - trastuzumab - stomach neoplasms; breast neoplasms - antineoplastic agents - breast cancermetastatic breast cancertrazimera 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 cancertrazimera 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 cancertrazimera 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-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.trazimera should only be used in patients with metastatic gastric cancer (mgc) whose tumours have her2 overexpression as defined by ihc2+ and a confirmatory sish or fish result, or by an ihc 3+ result. accurate and validated assay methods should be used.

Zirabev União Europeia - inglês - EMA (European Medicines Agency)

zirabev

pfizer europe ma eeig - bevacizumab - colorectal neoplasms; breast neoplasms; carcinoma, non-small-cell lung; carcinoma, renal cell; uterine cervical neoplasms - antineoplastic agents - zirabev in combination with fluoropyrimidine-based chemotherapy is indicated for treatment of adult patients with metastatic carcinoma of the colon or rectum.zirabev in combination with paclitaxel is indicated for first-line treatment of adult patients with metastatic breast cancer. for further information as to human epidermal growth factor receptor 2 (her2) status.zirabev, in addition to platinum-based chemotherapy, is indicated for first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-small cell lung cancer other than predominantly squamous cell histology.zirabev in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.zirabev, in combination with paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy, is indicated for the treatment of adult patients with persistent, recurrent, or metastatic carcinoma of the cervix.