FDA approved AstraZeneca’s vandetanib for treatment of medullary thyroid cancer. The drug, previously tested and rejected for non small cell lung cancer and bladder cancer, will carry a Risk Evaluation and Mitigation Strategy because it can affect the electrical activity of the heart and cause an irregular heartbeat. Medullary thyroid cancer cases make up 3%-5% of the 44,600 thyroid cancers diagnosed each year in the US. In a 331-person clinical trial of people with late-stage medullary thyroid cancer, average progression-free survival in patients taking vandetanib was 22.6 months – 6.2 months better than that for patients taking a placebo.
GlaxoSmithKline and XenoPort drug Horizant won FDA approval for the treatment of moderate-to-severe primary restless legs syndrome. The first-in-class drug was delayed last year due to cancer worries but got the go-ahead after two 12-week clinical trials in adults demonstrated efficacy. The drug will carry a medication guide warning of a risk of suicidality because the active ingredient, gabapentin enacarbil, becomes gabapentin in the body, and gabapentin, used as an anti-seizure medication, is associated with a small risk of suicidal thoughts and actions.
