On May 26, 2023, Bristol Myers Squibb announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of OPDIVO (nivolumab) with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) in adult patients at high risk of recurrence, with tumor cell PD-L1 expression of 1% or higher. The recommendation is now under review by the European Commission (EC), which holds the authority to approve medications for the European Union (EU).
“The devastating reality is that despite progress in lung cancer treatment, many patients still ultimately end up relapsing and potentially dying of their disease,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “Based on the results of the CheckMate -816 trial, Opdivo with chemotherapy is the first immunotherapy-based regimen to reduce the risk of disease recurrence, progression and death in resectable NSCLC when given before surgery. The CHMP’s recommendation moves us another step closer to addressing the pressing need to offer certain patients in the European Union a chance to change the course of their disease with an effective and tolerable pre-surgical option that may help reduce the risk of relapse.”
Opdivo (nivolumab) has received a positive opinion based on the remarkable results from the CheckMate -816 trial, showcasing its significant impact in the treatment of resectable non-small cell lung cancer (NSCLC). The study demonstrated a meaningful improvement in event-free survival (EFS) and pathologic complete response (pCR) when Opdivo was combined with chemotherapy, surpassing the efficacy of chemotherapy alone. This groundbreaking approach has the potential to transform the NSCLC market.
The safety profile of Opdivo in combination with chemotherapy aligns with previous studies in NSCLC, ensuring patient well-being throughout the treatment journey. The impressive three-year data presented at the European Lung Cancer Congress 2023 confirms the durable clinical benefits of this combination therapy.
Opdivo has already gained approval for neoadjuvant treatment in resectable NSCLC in several countries, including the United States, Japan, and China. Furthermore, its potential extends to other tumor types such as bladder cancer, esophageal/gastroesophageal junction cancer, and melanoma, solidifying its position as a game-changer in the field of immuno-oncology.
As additional regulatory applications are being reviewed by global health authorities, the impact of Opdivo on the NSCLC market is poised to be substantial. This innovative treatment approach holds the promise of revolutionizing the standard of care and improving outcomes for patients battling this devastating disease.
