The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) supplemental biologics licence application (sBLA) for an Opdivo (nivolumab) and Yervoy (ipilimumab) combo as a first-line treatment for unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC).
The potential treatment is intended for the adult and paediatric patient population aged 12 years and above.
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The regulatory agency gave the application breakthrough therapy designation and priority review status and provided a Prescription Drug User Fee Act goal date of 23 June 2025.
The sBLA submission is supported by outcomes from the Phase III CheckMate -8HW trial, which showed that the combination achieved progression-free survival in comparison to the investigator’s choice of chemotherapy in the first-line setting and Opdivo monotherapy throughout all therapy lines, as per blinded independent central review (BICR) evaluation.
The trial continues to evaluate secondary endpoints, which include overall survival.
Bristol Myers Squibb Opdivo global programme lead and vice-president Dana Walker stated: “Today’s milestone brings us one step closer to providing an effective dual immunotherapy treatment option to adult and paediatric patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer.”
In July 2018, the US regulator approved the combo for treating adult and paediatric individuals aged 12 and over with MSI-H or dMMR mCRC that had advanced after treatment with oxaliplatin, irinotecan and fluoropyrimidine.
In December 2024, the combination gained European Union (EU) approval. In October it had also gained approval from the China National Medical Products Administration for the first-line treatment of adults with MSI-H or dMMR unresectable or mCRC.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor approved in 65 countries and regions which include Japan, the US, the EU and China.
In October 2024, the FDA approved Opdivo for treating adults with resectable non-small cell lung cancer (NSCLC).
