Quick Hits: FDA Approves Biologic Keytruda For Cancer

FDA Approves Biologic Keytruda For Genetic Defects Cancer
FDA Approves Biologic Keytruda For Genetic Defects Cancer

The FDA gave accelerated approval to the biologic Keytruda (pembrolizumab) for patients whose solid cancer tumors have a specific genetic feature. This is the first time the agency has approved a drug based on a such a feature, also known as a biomarker. In the past, the FDA has approved cancer treatments based on where in the body the cancer started (e.g., lung or breast cancers). Patients taking Keytruda should take precautions as the medication can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs, colon, liver, endocrine glands and kidneys. Additionally, it may cause harm to a developing fetus or newborn baby. Posted May 23, 2017. Via FDA.

Prescription drug prices increased by an average 8.8% in 2016. This represents the fourth consecutive year of inflation above 8%, according to data from the Truveris National Drug Index. Over the last 3 years, the average annual price increase was nearly 10%. Furthermore, drug prices inflated 318% more than the price of all goods in the US. Posted May 10, 2017. Via PR Newswire.

The FDA’s Office of Prescription Drug Promotion sent a warning letter to Orexigen Therapeutics for a television advertisement that conveyed a misleading impression about the safety of its weight loss drug Contrave. The TV ad fails to disclose any information about neuropsychiatric reactions discussed in the Boxed Warning section of the labeling for Contrave (naltrexone/bupropion). The TV ad misleadingly suggests that Contrave is safer than has been demonstrated by omitting serious risks associated with the medication, according to the FDA. Orexigen has until June 2 to respond to the letter. Posted May 18, 2017. Via FDA.

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