Trazimera, a Biosimilar to Herceptin, Gets FDA Approval

The FDA has approved Trazimera (trastuzumab-qyyp; Pfizer), a biosimilar to Herceptin (trastuzumab; Genentech).

The Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp; Pfizer), a biosimilar to Herceptin (trastuzumab; Genentech).

Trazimera, a HER2/neu receptor antagonist, is indicated for adjuvant treatment of HER2-overexpressing node positive or node negative (ER/PR negative or with 1 high risk feature breast cancer) as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy.

In addition, it is approved for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, and as a single agent, for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease.

Trazimera is also approved for use in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

The FDA approval was based on data demonstrating that Trazimera is highly similar to the reference product for the approved indications. Findings from a comparative study, REFLECTIONS B327-02, showed a similar objective response rate with Trazimera vs Herceptin in patients receiving first-line treatment for HER2-positive metastatic breast cancer. In addition, there were no clinically meaningful differences noted between Trazimera and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics when used for adjuvant treatment in patients with operable HER2-positive breast cancer.

Like the reference product, Trazimera carries a Boxed Warning describing cardiomyopathy, infusion reactions, embryo-fetal toxicity, and pulmonary toxicity.

Trazimera will be supplied as 420mg lyophilized powder in a multiple-dose vial for reconstitution. Prior to treatment, HER2 testing using FDA-approved tests should be performed. The product should not be substituted for or with ado-trastuzumab emtansine.

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