AMGen, Inc., the world’s current largest independent biotechnology company, received its sixth U.S. drug approval within only the past 12 months. The latest is a novel cancer immunotherapy for injection into melanoma lesions and lymph nodes of patients with inoperable skin cancer. The drug is an engineered version of a herpes virus that destroys cancer cells when injected directly into the lesions on or under the skin. At the same time, it also primes the immune system to attack the disease.
The drug was initially developed by BioVex, Inc. and was then acquired by AMGen in 2011. It is chemically known as talimogene laherparepvec (T-VEC). It is an oncolytic (cancer-killing) virus and the first to be approved by the United States. The drug was also favorably received in Europe, where AMGen is also awaiting approval. The U.S. approval was widely expected after an advisory panel to the U.S. FDA voted 22-1 to support its approval in April, despite a lack of definitive overall survival data on the treatment.
It’s Availability and Use
The drug, which will be sold under the brand Imlygic, is expected to have an average cost of about $65,000. It should be available to U.S. patients within a week. The company said it is still studying the drug in combination with other immunotherapies in advanced melanoma and other solid tumor cancers. The success of T-VEC in obtaining approval shows how essential viruses can be as a vector to stimulate immune response and fight cancer.