Merck, Pfizer’s avelumab clears first hurdle in early access scheme

This signifies that the Medicines and Healthcare products Regulatory Agency believes the drug is a potential candidate for the UK’s Early Access to Medicines Scheme, which allows patients with life-threatening and seriously debilitating conditions to be treated with innovative therapies before regulatory approval is obtained.

In the second stage of the process, the Agency will issue an EAMS Scientific Opinion if the quality, safety and efficacy data provided in support of the application is sufficient to support a positive benefit/risk balance and added clinical value, paving the way for patient access.

Medicines in the EAMS will typically be commissioned by NHS England through its specialised commissioning arrangements, but funded by pharmaceutical companies, enabling patients to benefit from the latest treatment breakthroughs at no cost to the NHS.

MCC is a rare and aggressive skin cancer affecting around 2,500 Europeans a year. Patients face a very bleak prognosis, with less than 20 percent surviving beyond five years.

Avelumab was filed with European regulators in November last year on the back of data from JAVELIN Merkel 200, a multicenter, single-arm, open-label, Phase II study of 88 patients with metastatic MCC whose disease had progressed after at least one chemotherapy treatment.

The data, published in the Lancet Oncology, showed durable responses to drug; the proportion of patients who achieved an objective response was 28 (31.8 percent) of 88 patients, including eight complete responses and 20 partial responses.

The drug, a fully human anti-PD-L1 IgG1 monoclonal antibody being evaluated across more than 15 different tumour types, has just received a marketing recommendation for MCC from the European Medicines Agency’s Committee for Medicinal products for Human Use, taking patients closer to having access to the first drug specifically indicated for the disease.