November 04, 2015
FDA Approves First-Of-Its-Kind Skin Cancer Drug
Bloomberg News (10/28, Chen) reports that the Food and Drug Administration approved Imlygic (talimogene laherparepvec), Amgen Inc.’s “treatment for melanoma lesions in the skin and lymph nodes that can’t be removed completely by surgery.” Imlygic, also known as T-vec, “uses a modified version of the herpes simplex virus to attack cancer cells.” The drug will have an average cost of about $65,000 annually, according to the company.
The Boston Globe (10/28, Tedeschi) reports in “Stat” that the drug is “the first tumor-killing virus to receive the FDA’s blessing” and it could “usher in a new wave of immune-stimulating viral therapies.” Other immune-stimulating viral therapies include “a genetically tweaked poliovirus being tested in patients with brain tumors, while another, based on a version of the common cold virus, is now under evaluation in people with bladder cancer.”
The AP (10/28) reports that “despite the drug’s groundbreaking approach, FDA officials stressed it has not been shown to extend life,” but rather has been demonstrated to shrink tumors. The NBC News (10/28, Fox) website reports that side effects of the drug “include fatigue, chills, fever, nausea, flu-like symptoms and pain at the injection site.” The treatment can also give the patient herpes simplex 1. Also covering the story are Reuters (10/28, Berkrot), MedPage Today (10/28, Bankhead), Medscape (10/28, Nelson), and OncLive (10/28, Midthun).