Bristol Myers announces EMA’s CHMP recommended approval of Opdivo

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended approval of Opdivo, or nivolumab, in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission, or EC, which has the authority to approve medicines for the European Union, will now review the CHMP recommendation. The final EC decision is expected in June 2024. The positive CHMP opinion is based on results from a sub-study of the CheckMate -901 trial which were presented at the European Society of Medical Oncology, or ESMO, Congress 2023. In the sub-study, Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival and progression-free survival as assessed by Blinded Independent Central Review. With a median follow up of approximately 33 months, treatment with Opdivo in combination with cisplatin and gemcitabine reduced the risk of death by 22%, demonstrating a median OS of 21.7 months versus 18.9 months with cisplatin-gemcitabine alone. Patients receiving Opdivo in combination with cisplatin and gemcitabine had their risk of disease progression or death reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months with cisplatin-gemcitabine alone.