Bristol-Myers Squibb (BMS, NYSE: BMY) has announced additional indication approval from China’s National Medical Products Administration (NMPA) for its anti-PD-1 therapy Opdivo (nivolumab). The approved regimen combines Opdivo with Yervoy (ipilimumab) and platinum-based chemotherapy as neoadjuvant therapy, followed by adjuvant Opdivo monotherapy post-surgery. This treatment is designated for adult patients with surgically resectable stage II, IIIA, and IIIB non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
Clinical Trial Basis
The approval is supported by results from the Phase III CheckMate-77T trial, which demonstrated statistically significant improvements in event-free survival (EFS) for the Opdivo-based regimen in resectable NSCLC. This trial underscores the efficacy of the combination therapy in improving outcomes for patients with early-stage NSCLC.
Market Impact
Opdivo is now the only immunotherapy in China with dual indications for resectable NSCLC, covering both perioperative (neoadjuvant/adjuvant) and standalone neoadjuvant settings. This expansion of indications solidifies Opdivo’s position as a leading treatment option for NSCLC patients, offering new hope for improved survival rates and quality of life.-Fineline Info & Tech
