European Commission approves Bristol-Myers Squibb’s Opdivo inhibitor
The European Commission has approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical hodgkin lymphoma (cHL).
The approval of Opdivo will allow its expanded marketing in relapsed or refractory cHL in all 28 Member States of the EU.
It is based on an analysis of data from the Phase II CheckMate -205 and the Phase I CheckMate -039 trials, evaluating patients with cHL after ASCT and treatment with brentuximab vedotin.
Bristol-Myers Squibb senior vice-president and chief strategy officer Emmanuel Blin said: “We’re incredibly proud of this approval for Opdivo and what it means for adult patients with relapsed or refractory classical hodgkin lymphoma after autologous stem cell transplant and treatment with brentuximab vedotin, as it marks the first and only PD-1 inhibitor approved for a hematologic malignancy in the EU.
“This is also Bristol-Myers Squibb’s second Immuno-Oncology agent approved for a blood cancer in the EU within just six months.”
Opdivo is associated with warnings and precautions, including immune-related such as pneumonitis, colitis, hepatitis, nephritis and renal dysfunction, endocrinopathies, rash, and other adverse reactions.
The safety of Opdivo in cHL was evaluated in 263 adult patients from CheckMate -205 (n=240) and CheckMate -039 (n=23).
The programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo has been designed to harness the body’s own immune system to help restore anti-tumour immune response.
Its global clinical development programme is based on the company’s scientific expertise in the field of immuno-oncology and includes various clinical trials across all phases.
To date, the programme has enrolled more than 25,000 patients and the trials have contributed to gaining a better understanding of the potential role of biomarkers in patient care.