Bristol-Myers Squibb issued the following announcement on July 31.
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumor types in the European Union (EU).
“Stage III and IV melanoma patients are at high risk for disease recurrence after surgical removal and, therefore, in need of effective interventions to prevent recurrence,” said James Larkin, M.D., Ph.D., Consultant Medical Oncologist, The Royal Marsden. “This is an important new treatment option, as the data support the benefit of nivolumab across a broad range of patients to address concerns around recurrence post-surgery.”
The EU approval is based on results from the ongoing Phase 3 randomized double-blind CheckMate -238 trial, which studied Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma according to the AJCC Cancer Staging Manual 7th edition. The 18-month recurrence-free survival (RFS) was 66.4% for Opdivo (95% CI: 61.8 to 70.6) versus 52.7% for Yervoy (95% CI: 47.8 to 57.4). Meanwhile, Opdivo reduced the risk of disease recurrence by 35% versus Yervoy (HR 0.65; 95% CI: 0.53 to 0.80; p <0.0001). Additionally, adjuvant treatment with Opdivo was well tolerated, with 14.4% of patients experiencing treatment-related grade 3/4 adverse events and 9.7% discontinuing due to toxicity
In December 2017, the U.S. Food and Drug Administration (FDA) approved Opdivo as an adjuvant therapy to treat melanoma patients with involvement of lymph nodes or metastatic disease who have undergone complete resection.
“We are excited that Opdivo has become the first PD-1 agent to receive an approved indication from the EU in the adjuvant setting,” said Fouad Namouni, M.D., head of oncology development, Bristol-Myers Squibb. “Today’s approval helps strengthen patients’ confidence in reducing the risk of recurrence and progression of melanoma after primary treatment and furthers our commitment to continuously explore new approaches that benefit more patients.”
Original source can be found here.