American biopharmaceutical firm Amgen announced on Friday, Oct. 23, that the European Medicines Agency (EMA) has issued a positive opinion for the approval of the company's virus-based cancer treatment talimogene laherparepvec (T-Vec).
Amgen said that the EMA's Committee for Medicinal Products for Human Use (CHMP) has recommended T-Vec to be approved for use in treating adults diagnosed with undetectable melanoma that is distantly metastatic or with no regional indication of brain, lung, bone or other forms of visceral disease.
Talimogene laherparepvec, known commercially as Imlygic, is an oncolytic immunotherapy designed to kill cancer cells and trigger an immune response against the formation of tumors. The treatment is derived from the cold sore virus called HSV-1 and administered through intralesional injection.
"We are pleased that Imlygic has received a positive opinion from the CHMP," Dr. Sean E. Harper, Amgen's executive vice president for research and development, said.
"If approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients."
The positive opinion from the CHMP centered on the results of a global and randomized phase three trial that evaluated the safety and efficacy of T-Vec in melanoma patients when there is no recommendation for resection.
The study showed a significant improvement in the durable response rate (DRR) in the 436 patients involved in the trial.
DDR pertains to the percentage of patients that manifested either partial response (PR) or complete response (CR) continuously maintained throughout a six-month period.
The CHMP's opinion echoes the result of subgroup analyses wherein the drug's effect on overall survival was most observed in individuals diagnosed with undetectable melanoma that has yet to spread beyond the lymph nodes or the skin.
Treatment-related side effects of T-Vec include nausea, chills, fatigue and pyrexia. There have also been reports of adverse events such as injection-site pain and illness similar to influenza.
Around 98 percent of reported adverse reactions were considered mild to moderate in their severity overall.
Melanoma
Considered to be the most severe and aggressive form of skin cancer in the world, melanoma remains a serious public health issue for the European Union.
The disease develops through the uncontrolled spread of cells known as melanocytes, which are responsible for providing the skin with pigment.
Researchers estimated that there were around 56,000 new cases of melanoma in Spain, France, Germany, Italy and the United Kingdom in 2012. It led to the deaths of 9,500 individuals during the same period.
Photo: Yale Rosen | Flickr
