Drug Update: September 2017

New Specialty Drug Approval

FDA Approves First Gene Therapy: Kymriah®

On August 30th 2017, the U.S. Food and Drug Administration (FDA) approved the first gene therapy for use in the United States. Kymriah® (tisagenlecleucel) is a cell-based gene therapy approved for the treatment of patients up to 25 years of age with refractory or relapsed (second or later relapse) B-cell precursor acute lymphoblastic leukemia (ALL). ALL is the most common childhood cancer in the United States with approximately 3,100 patients 20 years of age and younger diagnosed each year. It is a cancer of the bone marrow and blood which results in abnormal production of lymphocytes (a type of white blood cell). Fifteen to 20% of patients with ALL experience relapsed or refractory disease. Read more

Drug Update: August 2017

New Specialty Drug Approvals

FDA Approves New Hepatitis C Medication: Mavyret®

Hepatitis C is a viral disease that causes inflammation of the liver, which can lead to decreased liver function and in some cases liver failure. According to the Centers for Disease Control and Prevention (CDC), an estimated 2.7 to 3.9 million people in the United States have chronic hepatitis C virus (HCV). There are six known HCV genotypes; genotype 1 is the most common affecting approximately 75% of Americans with HCV. Read more