Bristol-Myers Squibb Company announced the approval of Opdivo (nivolumab) by the European Commission (EC). It was approved as a monotherapy in treating squamous cell cancer of the head and neck (SCCHN) in adults following or progressing on platinum-based therapy. Opdivo became the first and only Immuno-Oncology (I-O) treatment with showed improvement in overall survival (OS) in a Phase 3 trial for these patients. In addition, the results from CheckMate-141 played a crucial role in approval. It was an open-label, randomized, and global Phase 3 trial. The prime endpoint was OS, and secondary endpoints included objective response rate (ORR) and progression-free survival (PFS). The investigation of Opdivo versus investigator’s choice of therapy was conducted in patients of age 18 and above with platinum-refractory SCCHN. Methotrexate, docetaxel, or cetuximab were among investigator’s choice of therapy. Therapy was administered in the primary, adjuvant, neo-adjuvant, or metastatic setting. Patients had tumor progression at that time or within six months of undergoing platinum-based therapy.
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“The European Commission’s approval of Opdivo marks not only the first new treatment option in 10 years for patients with advanced cancers of the head and neck, but also the first Immuno-Oncology treatment for SCCHN,” said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. “Bristol-Myers Squibb remains committed to redefining survival for patients with cancer, and now that Opdivo is approved in Europe, we will work collaboratively with EU health authorities to ensure it is available for these patients as quickly as possible.”
The safety profile of Opdivo in CheckMate-141 found to be consistent with prior studies conducted in patients with melanoma and non-small cell lung cancer. Adverse reactions took place in 49% of patients who received Opdivo. The frequent adverse reactions took place in at least 2% of patients who received Opdivo included respiratory tract infection, pneumonia, respiratory failure, aspiration pneumonia, and sepsis.
Opdivo is useful for treating patients with classical Hodgkin lymphoma (cHL) that progressed or relapsed after post-transplantation brentuximab vedotin and autologous hematopoietic stem cell transplantation (HSCT). The overall response rate was responsible for the approval of Opdivo. In addition, continued approval can be contingent based on description and verification of benefits in confirmatory trials.
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