Trazimera Fourth Biosimilar to Herceptin Approved for HER2-Positive Breast Cancer or HER2-Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

April 2019, Vol 9, No 4 - FDA Approvals, News & Updates


On March 11, 2019, the FDA approved trastuzumab-qyyp (Trazimera; Pfizer) as the fourth biosimilar to trastuzumab (Herceptin; Genentech) for the treatment of patients with HER2-positive breast cancer or HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma. This approval was based on several studies confirming that trastuzumab-qyyp is biosimilar to the originator drug, Herceptin.

The most common (≥5%) adverse effects in the adjuvant breast cancer setting were headache, diarrhea, nausea, and chills. The most common (≥10%) adverse effects in the metastatic breast cancer setting were fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash; in patients with metastatic ­gastric cancer, these included neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia.