Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency
The MAA for talimogene laherparepvec contains data from more than 400 patients and is based on a global, randomized, open-label Phase 3 trial evaluating the safety and efficacy of talimogene laherparepvec in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
"The submission of the Marketing Authorization Application in
Melanoma is a type of skin cancer that is characterized by the uncontrolled growth of melanocytes, which are the cells responsible for providing the pigment to skin.1 Melanoma is the most aggressive and serious form of skin cancer. Currently, 132,000 melanoma cases occur globally each year.2 The number of people with melanoma is expected to rise considerably worldwide, with more than 279,000 projected new cases by the year 2020.3 Outcomes are substantially worse for people with regional and distantly metastatic disease, with high risk of recurrence for Stage IIIB, IIIC, and IV melanoma.4
Melanoma is considered to be advanced when it has spread, or metastasized, from the origin site to deeper parts of the skin or other organs such as the lymph nodes, lungs or other parts of the body distant from the primary tumor site.5
About Talimogene Laherparepvec
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumors (but not normal tissue) and to initiate an immune response to target cancer cells that have metastasized. Talimogene laherparepvec was designed to work in two important and complementary ways. First, it is injected directly into tumors where it replicates inside the tumor's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumor-derived antigens, along with GM-CSF, that can stimulate a system-wide immune response where white blood cells are able to seek out and target cancer that has spread throughout the body.
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The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the
3GLOBOCAN 2012 (IARC) -
4 Balch, J Clin Oncol. 2009.