medwireNews: The trastuzumab biosimilar Trazimera has been given a positive opinion for marketing authorization by the EMA.
The Committee for Medicinal Products for Human Use summary of opinion says the “[d]ata show that Trazimera has comparable quality, safety and efficacy” to the branded formulation.
The full indication for the biosimilar will include adult patients with HER2-positive metastatic breast cancer as a monotherapy after at least two lines of chemotherapy; use in combination with paclitaxel or docetaxel for treatment-naïve individuals unsuitable for anthracycline treatment; and use in combination with an aromatase inhibitor for hormone receptor-positive patients.
Trazimera may also be used for HER2-positive early breast cancer as a neoadjuvant or adjuvant therapy in combination with chemotherapy and/or radiotherapy, and for previously untreated patients with HER2-positive metastatic gastric or gastroesophageal junction cancer alongside capecitabine or 5-fluorouracil and cisplatin chemotherapy.
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