FDA approves another trastuzumab biosimilar for HER2-positive breast cancer, gastric cancer


The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.

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FDA approval was based on a review of a comprehensive data package, which included results from the REFLECTIONS B327-02 trial. In this trial, Trazimera was found to have clinical equivalence with trastuzumab in the first-line treatment setting in patients with HER2-positive metastatic breast cancer.

The most common adverse events associated with Trazimera in patients with breast cancer include fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cell counts, and muscle pain. For patients with metastatic adenocarcinoma, the most common adverse events include low white and red blood cell counts; diarrhea; fatigue; swelling of the mouth lining, mucous membranes, nose, or throat; weight loss; upper respiratory tract infections; fever; low platelet counts; and change in taste.

“Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients. With the availability of biosimilars like Trazimera in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” Mark Pegram, MD, director of the breast oncology program at the Stanford Women’s Cancer Center at Stanford (Calif.) University, said in the press release.

Find the full press release on the Pfizer website.

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