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Merck and Pfizer set to win NICE backing for Bavencio

The PD-L1 inhibitor is being assessed for the treatment of mMCC patients

Merck KGaA

Merck KGaA and Pfizer could receive a boost after the National Institute for Health and Care Excellence (NICE) took a step closer to recommending its checkpoint inhibitor Bavencio (avelumab) for people with a rare form of skin cancer.

In a final appraisal determination, the UK’s cost-effectiveness body is set to give the drug the all clear to treat patients with previously treated metastatic Merkel Cell Carcinoma (mMCC) as routine NHS use.

Additionally, NICE recommended Bavencio should be accessed via the Cancer Drugs Fund (CDF) for those with previously untreated mMCC.

Belinda Byrne, medical director at Merck, said: “Merck and Pfizer are really pleased with the decision by NICE, which will result in patients in England, Wales and Northern Ireland being able to access the first targeted systemic treatment option licensed in the UK for metastatic Merkel Cell Carcinoma.”

Patients with this disease typically have a ‘poor’ prognosis and according to the Journal of the American Academy of Dermatology, fewer than half of patients survive more than one year and fewer than 20% survive beyond five years.

Byrne added: “We have worked closely with NICE and the CDF to ensure all mMCC patients can get access to avelumab as early as possible in their treatment.”

While earlier-stage MCC can be generally managed with surgery and radiotherapy, treatment options for mMCC are ‘severely limited’.

However Bavencio, which became the first checkpoint inhibitor cleared in Europe for mMCC patients, was developed by Merck Serono as part of a $2.85bn oncology deal with Pfizer.

The pharma giants are expecting final guidance from NICE within the next coming weeks, and a decision by the Scottish Medicines Consortium (SMC) is also expected.

Despite the wait, the drug already seems to be making headway in the US after it claimed two approvals from the Food and Drug Administration (FDA) last year.

Article by
Gemma Jones

2nd March 2018

From: Regulatory



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