Amgen's First-of-its-Kind Skin Cancer Drug Wins U.S. Approvalby and
The medicine, known as T-vec, will be called Imlygic, FDA says
Imlygic is a genetically modified version of the herpes virus
Amgen Inc.’s therapy for a deadly form of skin cancer was approved by U.S. regulators, letting the drugmaker move forward even after a lackluster clinical trial.
The medicine, known as talimogene laherparepvec, or T-vec, was cleared as a treatment for melanoma lesions in the skin and lymph nodes that can’t be removed completely by surgery, the Food and Drug Administration said in a statement Tuesday. The brand-name of the drug is Imlygic, the FDA said.
T-vec uses a modified version of the herpes simplex virus to attack cancer cells. After being injected into the tumor, the virus replicates until it causes the cells to rupture. The destroyed cell releases bits of the tumor, provoking an immune system response that teaches the body to recognize the cancer. The immune system then can seek out cancer cells that have spread through the body and destroy them.
Amgen intends to make Imlygic available to U.S. patients within a week and anticipates the average cost of the drug will be about $65,000, the company said in a statement. A treatment course consists of a series of injections that will vary by patient.
Analysts haven’t had high expectations for T-vec since it missed overall survival goals in a final-stage trial. Patients taking T-vec in the trial lived a median 23.3 months, or 4.4 months longer than patients taking only a medication to stimulate white blood-cell production. Still, FDA advisers said in April that T-vec could be helpful to some patients, and that benefits outweighed risks of taking the drug for patients with advanced melanoma.
Melanoma is the deadliest form of skin cancer. The American Cancer Society estimates 73,870 new U.S. patients will be diagnosed with the disease this year and 9,940 will die from it.
Common side effects of the drug include fatigue, fever, nausea and flu-like symptoms. The herpes virus can also occur in patients so Imlygic shouldn’t be given to people with suppressed immune systems or who are pregnant, the FDA said.