Drug Safety for Targeted Cancer Treatment

While increased screening and early treatment have led to a decrease in breast cancer mortality, metastatic breast cancer (MBC) remains incurable. However, new treatments—using combinations of drugs—have the potential to turn MBC into a manageable, chronic disease. This would enable patients to live longer and have a higher quality of life.

Human epidermal growth factor receptor 2 (HER2) is a cell surface receptor that controls cell growth, survival, and differentiation. It frequently becomes amplified and/or over expressed in a significant percentage of breast cancer patients. Patients with HER+ tumors tend to experience increased tumor aggressiveness, higher rates of recurrence, and increased mortality. Thus, HER2 is an important target for managing HER2+ metastatic breast cancer (MBC).

The sponsor, a global pharmaceutical company, sought approval for pertuzumab, a targeted treatment that combined with trastuzumab and docetaxel gave patients with first-line MBC longer progression-free survival (PFS). Pertuzumab is a humanized monoclonal anti-HER2 antibody. It blocks HER2 heterodimerization to inhibit ligand-activated downstream cell signaling.

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