EU green light for Merck, Pfizer’s Bavencio

0
22

Adult patients with metastatic Merkel cell carcinoma (mMCC) in Europe stand to gain access to the first immunotherapy to treat the disease following regulatory approval of Merck and Pfizer’s Bavencio.

Around 2,500 Europeans are affected by MCC – a rare and aggressive form of skin cancer – each year, with metastatic disease diagnosed in 5–12 percent of patients. Less than 20 percent of patients with metastatic MCC survive beyond 5 years, highlighting the urgent need for new treatment approaches.

Bavencio (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.

Dirk Schadendorf, director of Dermatology at the University Hospital Essen, Germany, said approval of Bavencio “is a meaningful development for patients and their families suffering from this devastating disease.”

The drug, a fully human anti-PD-L1 IgG1 monoclonal antibody being evaluated across more than 15 different tumour types, is expected to become commercially available to patients in Europe by prescription within the coming months, with initial launches in Germany and UK expected as early as October 2017.

The European Union’s decision follows the US accelerated approvals for Bavencio earlier this year for the treatment of mMCC and patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.

The was also granted a green light by Swissmedic in September, for the treatment of patients with mMCC,whose disease has progressed after at least one chemotherapy treatment.

Comments

comments