Amgen skin cancer drug Imlygic rejected by NICE

pharmafile | March 16, 2016 | News story | Research and Development Amgen, Imlygic, NICE, melanoma, skin cancer 

NICE has rejected Amgen’s drug Imlygic (talimogene laherparepvec) in draft as a treatment for advanced melanoma that has spread and cannot be removed surgically, citing a lack of efficacy evidence.

Talimogene laherparepvec is an oncolytic immunotherapy derived from the herpes  simplex virus type-1 (HSV-1), which normally causes cold sores. Amgen modifies the drug to kill cancer cells both by directly attacking them and boosting the immune system’s ability to recognise and destroy them. Imlygic is injected directly into the skin tumour.

The European Commission approved the drug in December for patients whose tumour is unresectable and regionally or distantly metastatic.

Professor Carole Longson MBE, director of the Centre for Health Technology Evaluation at NICE, recognised that while the therapy represents an innovation in the skin cancer treatment space, and the committee was advised by patient and clinical experts that Imlygic has a better safety profile than other advanced melanoma drugs, the NICE was not convinced of its superiority to other options.

She comments: “The committee concluded that there was not enough evidence to be able to say whether talimogene laherparepvec is as clinically effective as other drugs used to treat advanced melanoma. Given the uncertainty about its effect on overall survival compared with these drugs, it was not possible to recommend talimogene laherparepvec as a cost-effective use of NHS resources.”

NICE recently made recommendations for other therapies in melanoma, in January recommending BMS’s Opdivo (nivolumab) for advanced forms of the disease. The UK watchdog has also recommended BMS’ Yervoy (ipilimumab) as a possible treatment for adults with advanced melanoma that has either not been treated before or that has previously been treated.

Another recommended therapy is MSD’s Keytruda (pembrolizumab), specifically for advanced melanoma used before and after prior treatment with Yervoy.

Consultees may comment on NICE’s draft guidance until April 13, and the Committee will release its next guidance on Imlygic April 19.

Joel Levy 

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