EMA issues positive opinion to Amgen’s advanced therapy, Imlygic™ (T-Vec)

On 23 October 2015, the European Medicine’s Agency (EMA) recommended the approval of Amgen’s Advanced Therapy Medicinal Product (ATMP), Imlygic™ (talimogene laherparepvec, or T-Vec for short). Imlygic™ is an oncolytic immunotherapy for the treatment of unresectable metastatic melanoma in adults that is regionally or distantly metastatic (Stage IIIB, IIIC and IVM1a) with no bone, brain, lung or other visceral disease.

Imlygic™ is the first ATMP based on a virus that has been genetically-engineered to enable it to specifically infect and kill tumour cells. This ‘oncolytic virus’ product is based on herpes simplex virus-1, and it’s mechanism of action involves the production of granulocyte-macrophage colony-stimulating factor (GM-CSF) in the tumour cells which it infects. The virus replicates within the infected tumour cells causing them to lyse and release GM-CSF and tumour-specific antigens, which together are thought to induce an immune response against the tumour cells. Imlygic™ has shown safety and efficacy in a global, randomized, open-label Phase 3 trial of 436 patients with Stage IIIB, IIIC or IV melanoma when resection was not recommended compared to granulocyte-macrophage colony-stimulating factor (GM-CSF) (see the Amgen press release for full details).

The EMA’s recommendation to approve Imlygic™ is the penultimate step towards a marketing authorisation (MA) being granted by the European Commission (EC). The EMA recommends that a MA is granted based on a positive opinion issued by the EMA’s Committee for Medicinal Products for Human Use (CHMP) following review of the marketing authorisation application (MAA). The CHMP is EMA’s scientific committee responsible for reviewing MAAs, and for the approval of ATMPs it takes expert advice from the Committee for Advanced Therapies (CAT). If granted a MA, Imlygic™ will be the sixth ATMP approved for use in the EU, together with Glybera,Provenge, ChondroCelect, MACI and Holoclar. Approval of Imlygic™ in the United States by the US Food and Drugs Administration (FDA) was granted on 27 October.

Author: Anthony Lodge

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