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Amgen's Imlygic recommended for European approval

First-in-class oncolytic immunotherapy wins CHMP positive opinion

Amgen's Imlygic has been granted a positive opinion by the Committee for Medicinal Products for Human Use for the treatment of unresectable melanoma. 

A potential first-in-class oncolytic immunotherapy, Imlygic is administered via intralesional injection and designed to cause the death of tumour cells.

Sean Harper, executive VP of research and development at Amgen, said: “We are pleased that Imlygic has received a positive opinion from the CHMP, and if approved by the European Commission, we look forward to continuing to work with European regulatory authorities to bring this innovative therapy to patients.

“Metastic melanoma continues to be one of the most difficult-to-treat cancers, often requiring the use of multiple treatment modalities. Despite recent advances, the five-year survival rate for patients who cannot be cured with surgery remains unacceptably low, demonstrating the critical need for additional approaches to control this disease.”

The positive opinion comes from a phase III trial evaluating the efficacy and safety of Imlygic in patients with Stage IIIB, IIIC or IV melanoma. 

In the 436-patient study, Imlygic significantly improved durable response rate, which is defined as the percentage of patients with complete response or partial response maintained for a minimum of six months.

Melanoma is a form of skin cancer characterised by uncontrolled growth of melanocytes, the cells responsible for providing skin pigmentation.

It is the most aggressive form of skin cancer and in 2012 there were around 56,000 new cases across several European countries causing nearly 10,000 deaths.

Amgen is currently in a number of immuno-oncology research partnerships, including a collaboration with Merck for Keytruda (pembrolizumab) as well as one with Roche to investigate the combination of Imlygic and the Swiss company's investigational anti-PDL1 therapy atezolizumab. 

Article by
Nikhil Patel

27th October 2015

From: Regulatory



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