The approval allows for marketing of Opdivo in all 28 member states of the European Union (EU) and it follows an accelerated assessment by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
Opdivo is the only PD-1 immune checkpoint inhibitor to receive an accelerated assessment in Europe, and is the first approval given by the EC for a PD-1 inhibitor in any cancer.
Bristol-Myers Squibb senior vice-president and head of commercialization, policy and operations Emmanuel Blin said: "At Bristol-Myers Squibb, we are continually focused on developing new ways to transform the outlook for patients with some of the hardest-to-treat and deadliest cancers.
"We are pleased to bring the first PD-1 immune checkpoint inhibitor to the European Union for the treatment of advanced melanoma.
"We are working relentlessly and at record-breaking speed to build upon our Immuno-Oncology science to deliver new treatment options, with the goal of improving long-term survival for patients."
The approval is based on two Phase III trials, CheckMate -066 trial showing superior overall survival vs. dacarbazine in the first-line setting and CheckMate -037 trial which showed improved response vs. chemotherapy in previously-treated patients, both at a consistent and well-established dose.
The randomized, double-blind Phase III CheckMate -066 trial compared Opdivo to the chemotherapy dacarbazine (DTIC) in patients with treatment-naïve advanced melanoma.
CheckMate -037 is a randomized, controlled open-label Phase III trial of Opdivo versus investigator’s choice chemotherapy (ICC) either single-agent dacarbazine or carboplatin plus paclitaxel in patients with advanced melanoma who were previously treated with Yervoy (ipilimumab), and, if BRAF mutation positive, a BRAF inhibitor.
Image: The European Commission approval allows for the marketing of Bristol-Myers’ Opdivo in all 28 member states of the EU. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.