CHMP Recommends Approval of Bristol Myers Squibb’s Opdivo® for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma

Bristol Myers Squibb (NYSE: BMY) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Opdivo® (nivolumab) combined with cisplatin and gemcitabine as the first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma. This recommendation will now undergo review by the European Commission (EC), with the final decision expected in June 2024.

Dana Walker, Vice President and Global Program Lead for Genitourinary Cancers at Bristol Myers Squibb, highlighted the significance of this recommendation for patients. Traditionally, platinum-based chemotherapy has been the standard first-line treatment for this patient population, but its efficacy wanes over time and patients face limited options upon progression. The positive CHMP opinion marks a step forward in potentially providing a new treatment avenue for eligible patients.

The recommendation stems from data presented at the European Society of Medical Oncology (ESMO) Congress 2023, specifically from a sub-study of the CheckMate -901 trial. In this sub-study, Opdivo in combination with cisplatin and gemcitabine, followed by Opdivo monotherapy, demonstrated notable improvements in overall survival (OS) and progression-free survival (PFS) compared to cisplatin-gemcitabine alone. The safety profile was consistent with the known profiles of the individual components, with no new safety concerns identified.

CheckMate -901 is a significant trial as it’s the first Phase 3 trial to show a survival benefit with an immunotherapy-chemotherapy combination compared to standard chemotherapy alone in the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.

This recommendation in Europe follows the recent approval by the U.S. Food and Drug Administration (FDA) on March 7, 2024, for the same indication, based on promising results from clinical trials. Opdivo has shown efficacy across various tumor types, including urothelial carcinoma, renal cell carcinoma, non-small cell lung cancer, and others.

Bristol Myers Squibb expresses gratitude to the patients and investigators involved in the CheckMate -901 clinical trial.

About CheckMate -901: CheckMate -901 is a Phase 3 trial evaluating Opdivo in combination with Yervoy or Opdivo with cisplatin and gemcitabine followed by Opdivo monotherapy compared to standard chemotherapy alone in patients with untreated, unresectable, or metastatic urothelial cancer. The primary endpoints are overall survival (OS) and progression-free survival (PFS).

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