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FDA Approval

FDA Approves Biosimilar for the Treatment of HER2-Positive Breast, Gastric Cancer

March 12, 2019

The US Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera, Pfizer Inc), a biosimilar to trastuzumab (Herceptin, Genentech), to treat human epidermal growth factor receptor-2 (HER2)-positive breast cancer as well as HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.

Approval was based on review of a comprehensive data package—including results from the REFLECTIONS B327-02 study—which showed a high degree of similarity between trastuzumab-qyyp and the originator product. REFLECTIONS B327-02 was published in the British Journal of Cancer and is a comparative study showing clinical equivalency between the two products in first-line HER2-overexpressing metastatic breast cancer.

“With the availability of biosimilars like Trazimera in the US, oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need,” said Mark Pegram, MD, Stanford Comprehensive Cancer Institute, in a press release (March 11, 2019).

Trastuzumab-qyyp was granted European Medicines Agency approval in July 2018 for the same indications. Side effects include fever and chills, nausea, vomiting, headache, dizziness, shortness of breath, and congestive heart failure.

“This is an important milestone in the US, which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” stated Andy Schmeltz, global president, Pfizer Oncology (March 11, 2019). “We are proud to be able to offer treatment options that can help address the diverse needs of patients.”—Zachary Bessette

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