Amgen Submits Marketing Authorization Application for Oncolytic Immunotherapy in EU

Editor’s note: Before a drug can be made widely available to patients in the European Union, it must first be approved by the European Medicines Agency. The drug company Amgen recently submitted a proposal for approval of its melanoma treatment talimogene laherparepvec (T-VEC). T-VEC is a modified virus that is injected directly into tumors, where it destroys tumor cells. It has shown some promising results in clinical trials—research studies in volunteer patients.

“Amgen announced the submission of a marketing authorization application to the European Medicines Agency for talimogene laherparepvec for the treatment of regionally or distantly metastatic melanoma in adults.

“If the application is approved, talimogene laherparepvec will represent the first in a class of novel agents known as oncolytic immunotherapies, according to a company press release.

“The marketing authorization application contains data from more than 400 patients and is based on a global, randomized, open-label, phase 3 trial evaluating its efficacy and safety in patients with stage IIIB, IIIC or IV melanoma when resection was not recommended.”