FDA Approvals, News & Updates

Cutaneous melanoma, although not the most common skin cancer, is the most deadly. Based on data collected between 2003 and 2009, the 5-year survival rate for Americans with metastatic melanoma remains very low—only 16%—for all disease stages and for both sexes. The National Cancer Institute has estimated that approximately 1 in 49 people will be diagnosed with melanoma in the United States, and more than 9450 people will die of this disease in 2013.

Glaucoma affects an estimated 2.2 million people in the United States, and is estimated to affect as many as 3 million people by 2020.1 Its prevalence is projected to rise with the aging of the US population.2 Glaucoma has the potential to destroy retinal ganglion cells in the optic nerve, which can lead to severe vision loss and blindness.1 In fact, glaucoma is a leading cause of blindness in the United States, accounting for 9% to 12% of all cases of blindness.3

Systemic juvenile idiopathic arthritis (SJIA) is a rare inflammatory disease, affecting approximately 10% of children diagnosed with juvenile idiopathic arthritis in the United States.1,2 The classic symptoms of SJIA include pain in the small joints of the hands, wrists, knees, and ankles; rash; and a high, spiking fever of ≥103°F that can last for weeks to months.3 By definition, SJIA can pre­sent at any point until the age of 16 years.

Prostate cancer is the second leading cause of cancer-related death in the United States among men and the most frequently diagnosed cancer in American males. Among patients with metastatic prostate cancer, up to approximately 90% have bone metastases.1 The median survival after the diagnosis of bone metastasis associated with prostate cancer is approximately 3 years.2

Approximately 25% of women who are diagnosed with breast cancer have HER2-positive tumors. The HER2 gene, which resides on chromosome 17, directs tumor cells to manufacture HER2 protein. This protein is a cell-surface receptor that compels the tumor cell to grow and to divide more frequently than normal, making HER2-positive breast cancer an aggressive phenotype.

Before the advent of HER2-directed therapies, patients diagnosed with HER2-positive disease had significantly shorter disease-free survival compared with patients with other breast cancer subtypes.1

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