Merck & Pfizer have announced the UK launch of BAVENCIO® (avelumab) solution for infusion 20 mg/mL, as a monotherapy for the treatment of metastatic Merkel Cell Carcinoma (mMCC) in adults.
BAVENCIO® (avelumab) is now the first treatment for this rare, aggressive type of skin cancer to be licensed for use in the UK.
Although it is hard to be accurate on how many cases of mMCC there are due to its low incidence, it is estimated that there are around 50 new cases of the disease each year in the UK.
Data do however show show that the incidence of MCC is rising, possibly due to an ageing population or increased UV exposure.
MCC exhibits aggressive clinical features, including frequent lymph node involvement and early metastases.
Patients with mMCC have a very poor prognosis, with fewer than half of patients surviving more than one year and fewer than 20% surviving beyond five years.
Although earlier-stage MCC can be generally managed with surgery and radiotherapy, treatment options for mMCC are severely limited. Until now, there have been no licensed medicines to treat mMCC in the UK and as such, the standard of care for patients with mMCC is to enrol in clinical trials.
The efficacy and safety of avelumab was demonstrated in the JAVELIN Merkel 200 trial, an international, multi-centre, single-arm, open-label, Phase II study with two parts (still
Catherine Bouvier, CEO of the NET Patient Foundation, said: “We’re really encouraged by the news that avelumab is now licensed for use in the UK. An effective, well-tolerated treatment option will be welcomed with open arms by patients with mMCC and their families, so we hope that all stakeholders will work in a collaborative way to ensure that patients in the UK now have access to it as quickly as possible.”
Dr Belinda Byrne, Medical Director at Merck, UK, said of the alliance between the companies: “It demonstrates our commitment to working in partnership to develop new treatment options for patients with hard-to-treat cancers and we are looking forward to exploring future potential monotherapy indications and a diverse range of novel combinations with avelumab.”
NICE is due to publish Technology Appraisal Guidance on avelumab in April 2018.