Pfizer’s Herceptin biosimilar Trazimera gets FDA nod

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Pfizer’s Herceptin biosimilar Trazimera gets FDA nod

By Sandra Levy - 03/12/2019
The Food and Drug Administration has greenlighted Pfizer’s Trazimera (trastuzumab-qyyp), a biosimilar to Genentech’s Herceptin (trastuzumab), for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

“This is an important milestone in the U.S. which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” Pfizer Oncology global president Andy Schmeltz said. “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”

“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,” said Mark Pegram, 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. “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.”

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