Trazimera, Herceptin Biosimilar, Gains FDA Approval

Pfizer’s biosimilar of originator biologic trastuzumab (Herceptin, Genentech), Trazimera has been approved by the FDA. It has been given the designation trastuzumab-gyyp and is indicated for breast cancers and metastatic gastric or gastroesophageal junction adenocarcinomas that overexpress the HER2 protein. This is the fourth biosimilar version of Herceptin to be approved. 

FDA approval was granted after a review of clinical data, including results from the REFLECTIONS B327-02 clinical comparative study published in the British Journal of Cancer. Results of the study indicate a high degree of similarity and no clinically significant differences between Trazimera and Herceptin for patients suffering from metastatic breast cancer.

Trastuzumab locks on to the HER2 protein present on the surface of some cancer cells and blocks the cell’s receptors, inhibiting cell division and growth. 

“Approximately 15% to 30% of breast cancers and 10% to 30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients,” says Mark Pegram, MD, lead author for the study. He is associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center in Palo Alto, CA.

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Prescribing Information

Warnings:

• Trastuzumab products may result in subclinical and clinical cardiac failure manifested as CHF and decreased LVEF. The greatest risk when administered concurrently with anthracyclines.

• Discontinue TRAZIMERA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

• Exposure to trastuzumab products during pregnancy can result in oligohydramnios, sometimes complicated by pulmonary hypoplasia and neonatal death.

Indications:

• Treatment of HER2-overexpressing breast cancer 

• Treatment of HER2-ocversexpressing metastatic gastric or gastroesophageal junction adenocarcinoma 

Contraindications: None

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