Categorized | Melanoma News, Regulatory

NICE u-turn in favour of Amgen’s novel melanoma drug

Source: Pharma Times, August 2016

The National Institute for Health and Care Excellence is now recommending NHS use of Amgen’s Imlygic to treat advanced melanoma that has spread and can’t be surgically removed.

The Institute has published final draft guidelines endorsing the drug as an option for treating unresectable, regionally or distantly metastatic (Stage IIIB, IIIC or IVM1a) melanoma that has not spread to bone, brain, lung or other internal organs, but only if: treatment with systemic immunotherapies is not suitable and; the company provides it with the discount agreed in the patient access scheme.

The decision marks a change in position from initial guidelines rejecting Imlygic (talimogene laherparepvec) in this setting, because of uncertainty over its effect on survival compared with other treatments, which the company has since addressed.
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