NEW YORK – Bristol Myers Squibb said on Monday that it has filed for European approval for its checkpoint inhibitor combination Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for metastatic colorectal cancer patients whose cancers have high microsatellite instability (MSI) or harbor mismatch repair deficiencies.
The European Medicines Agency has validated BMS's Type II variation application, meaning that the submission is complete and the EMA can begin its centralized review process.
In its application, BMS submitted data from the Phase III CheckMate-8HW clinical trial in which Opdivo plus Yervoy improved patients' progression-fee survival versus chemotherapy. The trial is still continuing so that BMS can determine whether the Opdivo-Yervoy combination outperforms single-agent Opdivo in this patient population.
Opdivo plus Yervoy is already approved in the US and the EU for metastatic MSI-high or dMMR colorectal cancer patients after prior treatment. In the US, Opdivo monotherapy is also approved in this setting.
Also on Monday, BMS said that it has filed an application with the US Food and Drug Administration seeking approval for a subcutaneous formulation of Opdivo, which would make the easier-to-administer version available across already approved Opdivo indications. Opdivo is currently only available in an intravenous formulation. The injection takes three to five minutes, whereas the IV drip could take up to an hour.
The FDA has accepted BMS's biologics license application, which includes data from the Phase III CheckMate-67T trial, showing that the injection was not inferior to IV Opdivo in certain kidney cancer patients, and that the two formulations had similar safety profiles.
The FDA expects to decide whether to approve subcutaneous Opdivo by Feb. 28, 2025. If approved, the decision will apply to all previously approved adult, solid tumor indications of Opdivo when given as a single agent, as a monotherapy maintenance drug after Opdivo-Yervoy, or as a combination agent with chemotherapy or Exelixis' tyrosine kinase inhibitor Cabometyx (cabozantinib).