Melanoma patients in England who have ceased responding to standard-of-care treatments can soon avail of a new immunotherapy drug that works by “unmasking” cancer cells and reprogramming the body’s immune system to recognize and destroy these abnormal cells. Keytruda (pembrolizumab)’s approval came after drug developer Merck, Sharp & Dohme price negotiation with the National Institute of Health and Care Excellence (NICE).
While clinical trials have not been able to demonstrate effectiveness in all patients, those who did respond to Keytruda demonstrated clinically significant improvements, without the harmful and debilitating side effects common to chemotherapy.
NICE’s approval ultimately means melanoma patients who have stopped responding to ipilimumab, another checkpoint immunotherapy agent, and other DNA-specific drugs can now consult their physician about possibly beginning treatment with Keytruda.
Professor Peter Johnson, Cancer Research UK’s chief clinician, said, “Pembrolizumab provides another option for patients with skin cancer which has spread around the body after they’ve tried other drugs. We’re pleased that NICE have acted quickly to make the drug available on the NHS in England and Wales.”
Professor Carole Longson, Director of NICE’s Health Technology Evaluation Centre added, “We are pleased to be able to recommend pembrolizumab, the first EAMS drug, in final draft guidance. I am sure this will be welcome news to patients and healthcare professionals alike.”
While this decision from NICE applies only to England, authorities in the Welsh Government normally follow suit, and the Northern Ireland Government has begun reviewing the possibility of accepting the guidance. The Scottish Medicines Consortium reported it was set to publish advice on Keytruda in November. Further, NICE is currently working on the possibility of making the drug available to patients earlier on from the time of diagnosis. The ruling on this is expected to come early 2016.
SciBase AB, a Swedish medical technology company headquartered in Stockholm, has recently announced the results of its US Reader Study. According to SciBase, the addition of Nevisense, which uses Electrical Impedance Spectroscopy (EIS) to categorize cellular structures and thereby detect malignancies, greatly improved the ability of dermatologists in accurately diagnosing melanoma. This reader study and its positive results fulfils the US Food and Drug Administration’s requirement of SciBase prior to filing a Pre-Market Approval (PMA) application.