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Amgen’s Melanoma Drug Imlygic Wins FDA Approval

T-vec treatment returned lackluster results in a clinical trial

A therapy for melanoma lesions in the skin and lymph nodes that can’t be removed completely by surgery was approved by the FDA despite the lackluster results of clinical trials, according to Bloomberg.

Talimogene laherparepvec, or T-vec (Imlygic, Amgen Inc.) 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 talimogene laherparepvec  available to U.S. patients within a week and anticipates the average cost of the drug will be about $65,000, the company said. 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 talimogene laherparepvec,  should not be given to people with suppressed immune systems or who are pregnant, the FDA said.

Source: Bloomberg, October 28, 2015.

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