Melanoma drug tested at Moffitt Cancer Center gets FDA approval

October 28, 2015

TAMPA, Fla. It was announced Tuesday that the U.S. Food and Drug Administration (FDA) approved a drug that was tested in clinical trials at Moffitt Cancer Center and designed to target melanoma. The drug, called Imlygic or Talimogene Laherparepvec (TVEC), is a genetically modified oncolytic viral therapy encoded with the gene for granulocyte-macrophage colony-stimulating factor (GM-CSF) indicated for the treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma..

Jonathan Zager, M.D., FACS., served as the principal investigator on the clinical trial at Moffitt. He is the Chair of Graduate Medical Education and a surgical oncologist and Senior Member in the Departments of Cutaneous Oncology and Sarcoma at Moffitt. He is also the Director of Regional Therapies at Moffitt’s Donald A. Adam Comprehensive Melanoma Research Center of Excellence.

The drug was developed by Amgen, one of the world’s leading biotechnology companies.

“This is an intralesional injection,” Zager says. “This is another possible way of treating a patient’s recurrent unresectable melanoma with minimal side effects through a different avenue. It is very well tolerated and in the randomized phase III trial was shown to significantly improve the durable response rate as well as overall response rates over GM-CSF alone.  Just over 10% of patients had a complete response on the Phase III trial with TVEC having complete disappearance of all their tumors”

TVEC is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). The drug causes the death of cells which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown.

“IMLYGIC is the first clinical and regulatory validation of an oncolytic virus as a therapy, which Amgen is proud to bring to patients with a serious form of skin cancer,” says Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Not all melanoma patients currently benefit from available therapies, and IMLYGIC represents an important new option that can provide unprecedented durable response for patients with this aggressive and complex disease,”

Dr. Zager was involved with the Phase 3 trial and recently published JCO paperon the results of the trial as well as serves as the principal investigator on an additional 3 clinical trials ongoing exploring the utility of TVEC in melanoma patients.

“This is a great addition to the new and growing armamentarium for treating the patient with metastatic melanoma,” Zager says. “It is easily administered and well-tolerated and has some impressive results.”

About Amgen

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

About Moffitt Cancer Center

Located in Tampa, Moffitt is one of only 45 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s excellence in research, its contributions to clinical trials, prevention and cancer control. Moffitt is the top-ranked cancer hospital in Florida and has been listed in U.S. News & World Report as one of the “Best Hospitals” for cancer care since 1999. With more than 4,600 team members, Moffitt has an economic impact in the state of $1.9 billion. For more information, visit, and follow the Moffitt momentum on Facebook, Twitter and YouTube.