Biopharmaceutical company Amgen has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) via the centralised procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic.
Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumour immune response. If approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies.
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 Authorisation Application in Europe for talimogene laherparepvec brings us a step closer to helping address an unmet medical need for patients with metastatic melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "This regulatory milestone, on the heels of our Biologics License Application submission to the US FDA, represents an important step for our pipeline and we look forward to working with the European Medicines Agency as it conducts its review of talimogene laherparepvec."
Melanoma is a type of skin cancer that is characterised 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. The number of people with melanoma is expected to rise considerably worldwide, with more than 279,000 projected new cases by the year 2020. Outcomes are substantially worse for people with regional and distantly metastatic disease, with high risk of recurrence for Stage IIIB, IIIC, and IV melanoma.
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 tumour site.
Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to selectively replicate in tumours (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 tumours where it replicates inside the tumour's cells causing the cell to rupture and die in a process called lysis. The rupture of the cancer cells can release tumour-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.