The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has recommended the approval of Bristol-Myers Squibb's nivolumab for an additional indication in India. The recommendation supports the use of nivolumab (Opdivo) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
The SEC's decision, made during a recent oncology meeting, considered a proposal from Bristol-Myers Squibb that included a request for a waiver of local phase III clinical trials. The committee reviewed safety and efficacy data from global clinical studies, noting that India was not a participant in these studies. The proposed indication has already been approved in the US, Europe, UK, Canada, and Brazil.
Phase IV Trial Requirement
While recommending approval, the SEC stipulated that Bristol-Myers Squibb must conduct a phase IV clinical trial in the Indian population for the proposed indication. The protocol for this phase IV study must be submitted within three months of receiving permission for the additional indication.
CheckMate-901 Trial Data
The recommendation is supported by data from the CheckMate-901 trial, a phase 3 study that evaluated nivolumab in combination with cisplatin and gemcitabine. Results from CheckMate-901 demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) compared to chemotherapy alone. These findings led to European Commission approval in May 2024, making Opdivo the first concurrent immunotherapy-chemotherapy regimen approved for first-line treatment of unresectable or metastatic urothelial carcinoma in the European Union.
The CheckMate-901 trial's safety profile was consistent with the known safety profiles of the individual components of the regimen, and no new safety concerns were identified.
Nivolumab's Existing Indications
Nivolumab is currently indicated as a single agent for the treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic melanoma. It is also approved for treating adult patients with metastatic non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. Additionally, nivolumab is used in combination with ipilimumab as a first-line treatment for adult patients with intermediate or poor-risk advanced renal cell carcinoma and certain cases of metastatic non-small cell lung cancer.
